Dataset Information

Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

ABSTRACT: INTRODUCTION:Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present. METHODS AND ANALYSIS:A pilot randomised, assessor and participant-blind, sham-controlled trial will be conducted. Eighty participants with chronic LBP will be randomly allocated to receive either (1) active tDCS + sensorimotor retraining or (2) sham tDCS + sensorimotor retraining. tDCS (active or sham) will be applied to the primary motor cortex for 20?min immediately prior to 60?min of supervised sensorimotor retraining twice per week for 10 weeks. Participants in both groups will complete home exercises three times per week. Feasibility, safety, pain, disability and pain system function will be assessed immediately before and after the 10-week intervention. Analysis of feasibility and safety will be performed using descriptive statistics. Statistical analyses will be conducted based on intention-to-treat and per protocol and will be used to determine trends for effectiveness. ETHICS AND DISSEMINATION:Ethical approval has been gained from the institutional human research ethics committee (H10184). Written informed consent will be provided by all participants. Results from this pilot study will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12616000624482.

SUBMITTER: Ouellette AL

PROVIDER: S-EPMC5577893 | biostudies-other | 2017 Aug

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

Ouellette Adam Louis AL Liston Matthew B MB Chang Wei-Ju WJ Walton David M DM Wand Benedict Martin BM Schabrun Siobhan M SM

BMJ open 20170821 8

<h4>Introduction</h4>Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide ...[more]

PMID: 28827229

Similar Datasets

Project description:The characteristic temporal relationship between actions and their sensory outcomes allows us to distinguish self- from externally generated sensory events. However, the complex sensory environment can cause transient delays between action and outcome calling for flexible recalibration of predicted sensorimotor timing. Since the neural underpinnings of this process are largely unknown this study investigated the involvement of the cerebellum by means of cerebellar transcranial direct current stimulation (ctDCS). While receiving anodal, cathodal, dual-hemisphere or sham ctDCS, in an adaptation phase, participants were exposed to constant delays of 150 ms between actively or passively generated button presses and visual sensory outcomes. Recalibration in the same (visual outcome) and in another sensory modality (auditory outcome) was assessed in a subsequent test phase during which variable delays between button press and visual or auditory outcome had to be detected. Results indicated that temporal recalibration occurred in audition after anodal ctDCS while it was absent in vision. As the adaptation modality was visual, effects in audition suggest that recalibration occurred on a supra-modal level. In active conditions, anodal ctDCS improved sensorimotor recalibration at the delay level closest to the adaptation delay, suggesting a precise cerebellar-dependent temporal recalibration mechanism. In passive conditions, the facilitation of inter-sensory recalibration by anodal ctDCS was overall stronger and tuned to larger delays. These findings point to a role of the cerebellum in supra-modal temporal recalibration across sensorimotor and perceptual domains, but the differential manifestation of the effect across delay levels in active and passive conditions points to differences in the underlying mechanisms depending on the availability of action-based predictions. Furthermore, these results suggest that anodal ctDCS can be a promising tool for facilitating effects of temporal recalibration in sensorimotor and inter-sensory contexts.

Project description:BACKGROUND:Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has been shown to improve common symptoms of neurological disorders like depressed mood, fatigue, motor deficits and cognitive dysfunction. tDCS requires daily treatment sessions in order to be effective. We developed a remotely supervised tDCS (RS-tDCS) protocol for participants with multiple sclerosis (MS) to increase accessibility of tDCS, reducing clinician, patient, and caregiver burden. The goal of this protocol is to facilitate home use for larger trials with extended treatment periods. In this study we determine the generalizability of RS-tDCS paired with cognitive training (CT) by testing its feasibility in participants with Parkinson's disease (PD). METHODS:Following the methods in our MS protocol development, we enrolled sixteen participants (n =?12 male, n =?4 female; mean age 66?years) with PD to complete ten open-label sessions of RS-tDCS paired with CT (2.0?mA?×?20?min) at home under the remote supervision of a trained study technician. Tolerability data were collected before, during, and after each individual session. Baseline and follow-up measures included symptom inventories (fatigue and sleep) and cognitive assessments. RESULTS:RS-tDCS was feasible and tolerable for patients with PD, with at-home access leading to high protocol compliance. Side effects were mostly limited to mild sensations of transient itching and burning under the electrode sites. Similar to prior finding sin MS, we found preliminary efficacy for improvement of fatigue and cognitive processing speed in PD. CONCLUSIONS:RS-tDCS paired with CT is feasible for participants with PD to receive at home treatment. Signals of benefit for reduced fatigue and improved cognitive processing speed are consistent across the PD and MS samples. RS-tDCS can be generalized to provide tDCS to a range of patients with neurologic disorders for at-home rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02746705 . Registered April 21st 2016.

Project description:INTRODUCTION:Binge eating disorder (BED) is a common mental disorder, closely associated with obesity. Existing treatments are only moderately effective with high relapse rates, necessitating novel interventions. This paper describes the rationale for, and protocol of, a feasibility randomised controlled trial (RCT), evaluating the combination of transcranial direct current stimulation (tDCS) and a computerised cognitive training, namely approach bias modification training (ABM), in patients with BED who are overweight or obese. The aim of this trial is to obtain information that will guide decision-making and protocol development in relation to a future large-scale RCT of combined tDCS+ABM treatment in this group of patients, and also to assess the preliminary efficacy of this intervention. METHODS AND ANALYSIS:66 participants with Diagnostic and Statistical Manual-5 diagnosis of BED and a body mass index (BMI) of ?25?kg/m2 will be randomly allocated to one of three groups: ABM+real?tDCS; ABM+sham?tDCS or a wait-list control group. Participants in both intervention groups will receive six sessions of ABM+real/sham tDCS over 3 weeks; engaging in the ABM task while simultaneously receiving bilateral tDCS to the dorsolateral prefrontal cortex. ABM is based on an implicit learning paradigm in which participants are trained to enact an avoidance behaviour in response to visual food cues. Assessments will be conducted at baseline, post-treatment (3 weeks) and follow-up (7 weeks post-randomisation). Feasibility outcomes assess recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments. Other outcomes include eating disorder psychopathology and related neurocognitive outcomes (ie, delay of gratification and inhibitory control), BMI, other psychopathology (ie, mood), approach bias towards food and surrogate endpoints (ie, food cue reactivity, trait food craving and food intake). ETHICS AND DISSEMINATION:This study has been approved by the North West-Liverpool East Research Ethics Committee. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ISRCTN35717198.

Project description:Although posttraumatic stress disorder (PTSD; DSM-V 309.82) and anxiety disorders (DSM-V 300.xx) are widely spread mental disorders, the effectiveness of their therapy is still unsatisfying. Non-invasive brain-stimulation techniques like transcranial direct current stimulation (tDCS) might be an option to improve extinction learning, which is a main functional factor of exposure-based therapy for anxiety disorders. To examine this hypothesis, we used a fear conditioning paradigm with female faces as conditioned stimuli (CS) and a 95-dB female scream as unconditioned stimulus (UCS). We aimed to perform a tDCS of the ventromedial prefrontal cortex (vmPFC), which is mainly involved in the control of extinction-processes. Therefore, we applied two 4 × 4 cm electrodes approximately at the EEG-positions F7 and F8 and used a direct current of 1.5 mA. The 20-min stimulation was started during a 10-min break between acquisition and extinction and went on overall extinction-trials. The healthy participants were randomly assigned in two double-blinded process into two sham stimulation and two verum stimulation groups with opposite current flow directions. To measure the fear reactions, we used skin conductance responses (SCR) and subjective ratings. We performed a generalized estimating equations model for the SCR to assess the impact of tDCS and current flow direction on extinction processes for all subjects that showed a successful conditioning (N = 84). The results indicate that tDCS accelerates early extinction processes with a significantly faster loss of CS+/CS- discrimination. The discrimination loss was driven by a significant decrease in reaction toward the CS+ as well as an increase in reaction toward the CS- in the tDCS verum groups, whereas the sham groups showed no significant reaction changes during this period. Therefore, we assume that tDCS of the vmPFC can be used to enhance early extinction processes successfully. But before it should be tested in a clinical context further investigation is needed to assess the reason for the reaction increase on CS-. If this negative side effect can be avoided, tDCS may be a tool to improve exposure-based anxiety therapies.

Dataset Information

Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

Publications

Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets