Alpha activity neuromodulation induced by individual alpha-based neurofeedback learning in ecological context: a double-blind randomized study.
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SUBMITTER: Grosselin F
PROVIDER: S-EPMC8445968 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder (ADHD) in several, mostly uncontrolled studies. This pilot study is designed to test the feasibility and safety of using a double-blind placebo feedback-controlled design and to explore the initial efficacy of individualized EEG-neurofeedback training in children with ADHD. Fourteen children (8-15 years) with ADHD defined according to the DSM-IV-TR criteria were randomly allocated to 30 sessions of EEG-neurofeedback (n = 8) or placebo feedback (n = 6). Safety measures (adverse events and sleep problems), ADHD symptoms and global improvement were monitored. With respect to feasibility, all children completed the study and attended all study visits and training sessions. No significant adverse effects or sleep problems were reported. Regarding the expectancy, 75% of children and their parent(s) in the active neurofeedback group and 50% of children and their parent(s) in the placebo feedback group thought they received placebo feedback training. Analyses revealed significant improvements of ADHD symptoms over time, but changes were similar for both groups. This pilot study shows that it is feasible to conduct a rigorous placebo-controlled trial to investigate the efficacy of neurofeedback training in children with ADHD. However, a double-blind design may not be feasible since using automatic adjusted reward thresholds may not work as effective as manually adjusted reward thresholds. Additionally, implementation of active learning strategies may be an important factor for the efficacy of EEG-neurofeedback training. Based on the results of this pilot study, changes are made in the design of the ongoing study.
| S-EPMC3051071 | biostudies-literature
Project description:ObjectiveTo assess the efficacy and safety of a remote electrical neuromodulation (REN) device for the acute treatment of migraine.BackgroundThere is a significant unmet need for novel effective well-tolerated acute migraine treatments. REN is a novel acute migraine treatment that stimulates upper arm peripheral nerves to induce conditioned pain modulation - an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. A recent pilot study showed that REN can significantly reduce headache. We have conducted a randomized, double-blind, sham-controlled study to further evaluate the efficacy and safety of REN for the acute treatment of migraine.MethodsThis was a randomized, double-blind, sham-controlled, multicenter study conducted at 7 sites in the United States and 5 sites in Israel. Two hundred and fifty-two adults meeting the International Classification of Headache Disorders criteria for migraine with 2-8 migraine headaches per month were randomized in a 1:1 ratio to active or sham stimulation. A smartphone-controlled wireless device was applied for 30-45 minutes on the upper arm within 1 hour of attack onset; electrical stimulation was at a perceptible but non-painful intensity level. Migraine pain levels were recorded at baseline, 2, and 48 hours post-treatment. Most bothersome symptoms (MBS) were also recorded. The primary efficacy endpoint was the proportion of participants achieving pain relief at 2 hours post-treatment (improvement from severe or moderate pain to mild or none, or from mild pain to none). Relief of MBS and pain-free at 2 hours were key secondary endpoints.ResultsActive stimulation was more effective than sham stimulation in achieving pain relief (66.7% [66/99] vs 38.8% [40/103]; therapeutic gain of 27.9% [CI95% , 15.6-40.2]; P < .0001), pain-free (37.4% vs 18.4%, P = .003), and MBS relief (46.3% vs 22.2%, P = .0008) at 2 hours post-treatment. The pain relief and pain-free superiority of the active treatment was sustained 48 hours post-treatment. The incidence of device-related adverse events was low and similar between treatment groups (4.8% [6/126] vs 2.4% [3/126], P = .499).ConclusionsREN provides superior clinically meaningful relief of migraine pain and MBS compared to placebo, offering a safe and effective non-pharmacological alternative for acute migraine treatment.
| S-EPMC6767146 | biostudies-literature
Project description:ObjectiveTo examine delayed effects of theta-beta ratio (TBR) neurofeedback (NF) for attention-deficit/hyperactivity disorder (ADHD) 25 months after baseline, ∼21 months after end of treatment.MethodChildren aged 7 to 10 years with rigorously diagnosed ADHD had been randomized to 38 sessions of TBR NF (n = 84) or control treatment (n = 58) of identical appearance, intensity/frequency, and duration, differing only in that reinforcement for controls was based on a pre-recorded electroencephalogram (EEG) of another child. Child, parent, and all site staff were blinded until after 25-month assessments, with only one-fourth able to guess the control treatment correctly. Baseline assessments were repeated off medication after 25 months.ResultsOf the 142 participants, 120 had 25-month follow-up (84.5% retention). Only 12 participants (6 controls) had NF after the study treatment, greatly retaining the randomization. The primary outcome, parent-rated inattention, was not significantly different between treatments despite large pre-post effect sizes (NF recipients, d = 1.63; controls, d = 1.42). Most secondary measures showed the same pattern. Response rates (Clinical Global Impression-Improvement ≤2) were 58.6% of NF recipients and 66% of controls (not significant). Marginally more controls than NF recipients needed medication (57.1% vs 38.6%, p = .059); specifically, 7.1% of NF recipients and 4% of controls had reduced medication need, whereas 34.3% of NF recipients and 50% of controls needed more medication (p = 0.084).ConclusionMost of the large within-group improvement from the NF treatment package reported by unblinded studies and replicated in this blinded study reflects nonspecific effects, not specific effects of deliberate down-training of EEG theta-beta power ratio. At 25-month follow-up, it appears comparable to the evidence-based Multimodal Treatment Study of ADHD (MTA) treatments, suggesting a psychotherapeutic/behavioral effect.Clinical trial registration informationDouble-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; http://clinicaltrials.gov/; NCT02251743.Diversity & inclusion statementWe worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. We actively worked to promote sex and gender balance in our author group.
| S-EPMC10065891 | biostudies-literature
Project description:Studies have shown an association between sensorimotor α-oscillation and pain perception. It suggests the potential use of neurofeedback (NFB) training for pain modulation through modifying sensorimotor α-oscillation. Here, a single-session NFB training protocol targeted on increasing sensorimotor α-oscillations was applied to forty-five healthy participants. Pain thresholds to nociceptive laser stimulations and pain ratings (intensity and unpleasantness) to identical laser painful stimulations were assessed immediately before and after NFB training. Participants had larger pain thresholds, but rated the identical painful laser stimulation as more unpleasant after NFB training. These pain measurements were further compared between participants with high or low NFB training efficacy that was quantified as the regression slope of α-oscillation throughout the ten training blocks. A significant increase in pain thresholds was observed among participants with high-efficacy; whereas a significant increase in pain ratings was observed among participants with low-efficacy. These results suggested that NFB training decreased the sensory-discriminative aspect of pain, but increased the affective-motivational aspect of pain, whereas both pain modulations were dependent upon the NFB training efficacy. Importantly, correlation analysis across all participants revealed that a greater NFB training efficacy predicted a greater increase in pain thresholds particularly at hand contralateral to NFB target site, but no significant correlation was observed between NFB training efficacy and modulation on pain ratings. It thus provided causal evidence for a link between sensorimotor α-oscillation and the sensory-discriminative aspect of pain, and highlighted the need for personalized neurofeedback for the benefits on pain modulation at the individual level. Future studies can adopt a double-blind sham-controlled protocol to validate NFB training induced pain modulation.
| S-EPMC7566954 | biostudies-literature
Project description:AimA new closed-loop fMRI method called multi-voxel neuro-reinforcement has the potential to alleviate the subjective aversiveness of exposure-based interventions by directly inducing phobic representations in the brain, outside of conscious awareness. The current study seeks to test this method as an intervention for specific phobia.MethodsIn a randomized, double-blind, controlled single-university trial, individuals diagnosed with at least two (1 target, 1 control) animal subtype specific phobias were randomly assigned (1:1:1) to receive 1, 3, or 5 sessions of multi-voxel neuro-reinforcement in which they were rewarded for implicit activation of a target animal representation. Amygdala response to phobic stimuli was assessed by study staff blind to target and control animal assignments. Pre-treatment to post-treatment differences were analyzed with a 2-way repeated-measures ANOVA.ResultsA total of 23 participants (69.6% female) were randomized to receive 1 (n=8), 3 (n=7), or 5 (n=7) sessions of multi-voxel neuro-reinforcement. Eighteen (n=6 each group) participants were analyzed for our primary outcome. After neuro-reinforcement, we observed an interaction indicating a significant decrease in amygdala response for the target phobia but not the control phobia. No adverse events or dropouts were reported as a result of the intervention.ConclusionResults suggest multi-voxel neuro-reinforcement can specifically reduce threat signatures in specific phobia. Consequently, this intervention may complement conventional psychotherapy approaches with a non-distressing experience for patients seeking treatment. This trial sets the stage for a larger randomized clinical trial to replicate these results and examine the effects on real-life exposure.Clinical trial registrationThe now-closed trial was prospectively registered at ClinicalTrials.gov with ID NCT03655262.
| S-EPMC11312662 | biostudies-literature
Project description:Side effects play a key role in patients' failure to take antidepressants. There is evidence that verbal suggestions and informed consent elicit expectations that can in turn trigger the occurrence of side effects. Prior experience or learning mechanisms are also assumed to contribute to the development of side effects, although their role has not been thoroughly investigated. In this study, we examined whether an antidepressant's side effects can be learned via Pavlovian conditioning.Participants (n = 39) were randomly allocated to one of two groups and were exposed to a classical conditioning procedure. During acquisition, 19 participants received amitriptyline and 20 participants received a placebo pill. Pills were taken for four nights together with a novel-tasting drink. After a washout phase, both groups received a placebo pill together with the novel-tasting drink (evocation). Side effects were assessed via the Generic Assessment of Side Effects Scale prior to acquisition (baseline), after acquisition, and after evocation. A score of antidepressant-specific side effects was calculated.Participants taking amitriptyline reported significantly more antidepressant-specific side effects after acquisition compared to both baseline and the placebo group. After evocation, participants who underwent the conditioning procedure with amitriptyline reported significantly more antidepressant-specific side effects than those who never received amitriptyline, even though both groups received a placebo.Our results indicate that antidepressant side effects can be learned using a conditioning paradigm and evoked via a placebo pill when applied with the same contextual factors as the verum.
| S-EPMC5225191 | biostudies-other
Project description:ObjectiveTo determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback [NF]) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit.MethodIn a 2-site double-blind randomized clinical trial, 144 children aged 7 to 10 years with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR) ≥4.5 were randomized 3:2 to deliberate TBR downtraining versus a control of equal duration, intensity, and appearance. Two early dropouts left 142 children for modified intent-to-treat analysis. The control used prerecorded electroencephalograms with the participant's artifacts superimposed. Treatment was programmed via Internet by an off-site statistician-guided co-investigator. Fidelity was 98.7% by trainers/therapists and 93.2% by NF expert monitor. The primary outcome was parent- and teacher-rated inattention; analysis was mixed-effects regression. Because the expense and effort of NF can be justified only by enduring benefit, follow-ups were integrated.ResultsBlinding was excellent. Although both groups showed significant improvement (p < .001, d = 1.5) in parent/teacher-rated inattention from baseline to treatment end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d = 0.01, p = .965 at treatment end; d = 0.23, p = .412 at 13-month follow-up). Responders (Clinical Global Impression-Improvement [CGI-I] = 1-2) were 61% of NF and 54% of controls (p = .36). Adverse events were distributed proportionally between treatments. The 13-month follow-up found nonsignificant improvement from treatment end for NF (d = 0.1), with mild deterioration for controls (d = -0.07). NF required significantly less medication at follow-up (p = .012).ConclusionThis study does not support a specific effect of deliberate TBR NF at either treatment end or 13-month follow-up. Participants will be reassessed at 25-month follow-up.Clinical trial registration informationDouble-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; https://clinicaltrials.gov/; NCT02251743.
| S-EPMC7904968 | biostudies-literature
Project description:BackgroundSacral neuromodulation has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction, but its value in patients with a neurological cause is unclear. Although there is evidence indicating that sacral neuromodulation may be effective and safe for treating neurogenic lower urinary tract dysfunction, the number of investigated patients is low and there is a lack of randomized controlled trials.Methods and designThis study is a prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 sacral neuromodulation referral centers in Switzerland. Patients with refractory neurogenic lower urinary tract dysfunction are enrolled. After minimally invasive bilateral tined lead placement into the sacral foramina S3 and/or S4, patients undergo prolonged sacral neuromodulation testing for 3-6 weeks. In case of successful (defined as improvement of at least 50% in key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to baseline values) prolonged sacral neuromodulation testing, the neuromodulator is implanted in the upper buttock. After a 2 months post-implantation phase when the neuromodulator is turned ON to optimize the effectiveness of neuromodulation using sub-sensory threshold stimulation, the patients are randomized in a 1:1 allocation in sacral neuromodulation ON or OFF. At the end of the 2 months double-blind sacral neuromodulation phase, the patients have a neuro-urological re-evaluation, unblinding takes place, and the neuromodulator is turned ON in all patients. The primary outcome measure is success of sacral neuromodulation, secondary outcome measures are adverse events, urodynamic parameters, questionnaires, and costs of sacral neuromodulation.DiscussionIt is of utmost importance to know whether the minimally invasive and completely reversible sacral neuromodulation would be a valuable treatment option for patients with refractory neurogenic lower urinary tract dysfunction. If this type of treatment is effective in the neurological population, it would revolutionize the management of neurogenic lower urinary tract dysfunction.Trial registrationTrial registration numberhttp://www.clinicaltrials.gov; Identifier: NCT02165774.
| S-EPMC4139491 | biostudies-literature
Project description:BACKGROUND:Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. METHODS/DESIGN:Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35) or placebo training (n=35). Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. DISCUSSION:If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. TRIAL REGISTRATION:ClinicalTrials.gov NCT00961922.
| S-EPMC3530427 | biostudies-literature
Project description:BackgroundA pilot study has shown that real-time fMRI (rtfMRI) neurofeedback could be an alternative approach for chronic pain treatment. Considering the relative small sample of patients recruited and not strictly controlled condition, it is desirable to perform a replication as well as a double-blinded randomized study with a different control condition in chronic pain patients. Here we conducted a rtfMRI neurofeedback study in a subgroup of pain patients - patients with postherpetic neuralgia (PHN) and used a different sham neurofeedback control. We explored the feasibility of self-regulation of the rostral anterior cingulate cortex (rACC) activation in patients with PHN through rtfMRI neurofeedback and regulation of pain perception.MethodsSixteen patients (46-71 years) with PHN were randomly allocated to a experimental group (n = 8) or a control group (n = 8). 2 patients in the control group were excluded for large head motion. The experimental group was given true feedback information from their rACC whereas the control group was given sham feedback information from their posterior cingulate cortex (PCC). All subjects were instructed to perform an imagery task to increase and decrease activation within the target region using rtfMRI neurofeedback.ResultsOnline analysis showed 6/8 patients in the experimental group were able to increase and decrease the blood oxygen level dependent (BOLD) fMRI signal magnitude during intermittent feedback training. However, this modulation effect was not observed in the control group. Offline analysis showed that the percentage of BOLD signal change of the target region between the last and first training in the experimental group was significantly different from the control group's and was also significantly different than 0. The changes of pain perception reflected by numerical rating scale (NRS) in the experimental group were significantly different from the control group. However, there existed no significant correlations between BOLD signal change and NRS change.ConclusionPatients with PHN could learn to voluntarily control over activation in rACC through rtfMRI neurofeedback and alter their pain perception level. The present study may provide new evidence that rtfMRI neurofeedback training may be a supplemental approach for chronic clinical pain management.
| S-EPMC4388697 | biostudies-literature