Dataset Information

Continuous theta burst stimulation over the bilateral supplementary motor area in obsessive-compulsive disorder treatment: A clinical randomized single-blind sham-controlled trial.

ABSTRACT:

Background

Obsessive-compulsive disorder (OCD) can cause substantial damage to quality of life. Continuous theta burst stimulation (cTBS) is a promising treatment for OCD patients with the advantages of safety and noninvasiveness.

Objective

The present study aimed to evaluate the treatment efficacy of cTBS over the bilateral supplementary motor area (SMA) for OCD patients with a single-blind, sham-controlled design.

Methods

Fifty-four OCD patients were randomized to receive active or sham cTBS treatment over the bilateral SMA for 4 weeks (five sessions per week, 20 sessions in total). Patients were assessed at baseline (week 0), the end of treatment (week 4), and follow-up (week 8). Clinical scales included the YBOCS, HAMD₂₄, HAMA₁₄, and OBQ₄₄. Three behavioral tests were also conducted to explore the effect of cTBS on response inhibition and decision-making in OCD patients.

Results

The treatment response rates were not significantly different between the two groups at week 4 (active: 23.1% vs. sham: 16.7%, p = 0.571) and week 8 (active: 26.9% vs. sham: 16.7%, p = 0.382). Depression and anxiety improvements were significantly different between the two groups at week 4 (HAMD₂₄: F = 4.644, p = 0.037; HAMA₁₄: F = 5.219, p = 0.028). There was no significant difference between the two groups in the performance of three behavioral tests. The treatment satisfaction and dropout rates were not significantly different between the two groups.

Conclusions

The treatment of cTBS over the bilateral SMA was safe and tolerable, and it could significantly improve the depression and anxiety of OCD patients but was not enough to improve OCD symptoms in this study.

SUBMITTER: Guo Q

PROVIDER: S-EPMC9641651 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Continuous theta burst stimulation over the bilateral supplementary motor area in obsessive-compulsive disorder treatment: A clinical randomized single-blind sham-controlled trial.

Guo Qihui Q Wang Kaifeng K Han Huiqin H Li Puyu P Cheng Jiayue J Zhu Junjuan J Wang Zhen Z Fan Qing Q

European psychiatry : the journal of the Association of European Psychiatrists 20221007 1

<h4>Background</h4>Obsessive-compulsive disorder (OCD) can cause substantial damage to quality of life. Continuous theta burst stimulation (cTBS) is a promising treatment for OCD patients with the advantages of safety and noninvasiveness.<h4>Objective</h4>The present study aimed to evaluate the treatment efficacy of cTBS over the bilateral supplementary motor area (SMA) for OCD patients with a single-blind, sham-controlled design.<h4>Methods</h4>Fifty-four OCD patients were randomized to receive ...[more]

PMID: 36203323

Similar Datasets

Project description:BackgroundIntermittent theta burst stimulation (iTBS) when applied over the left dorsolateral prefrontal cortex (DLPFC) has been shown to be equally effective and safe to treat depression compared to traditional repetitive transcranial magnetic stimulation (rTMS) paradigms. This protocol describes a funded single-centre, double-blind, randomized placebo-controlled, clinical trial to investigate the antidepressive effects of iTBS and factors associated with an antidepressive response.MethodsIn this trial, outpatients (N = 96, aged 22-65 years) meeting the diagnostic criteria for at least moderate depression (Montgomery and Aasberg Depression Rating Scale score ≥ 20) will be enrolled prospectively and receive ten, once-a-day sessions of either active iTBS or sham iTBS to the left DLPFC, localized via a neuronavigation system. Participants may have any degree of treatment resistance. Prior to stimulation, participants will undergo a thorough safety screening and a brief diagnostic assessment, genetic analysis of brain-derived neurotropic factor, 5-HTTLPR and 5-HT1A, and cerebral MRI assessments. A selection of neuropsychological tests and questionnaires will be administered prior to stimulation and after ten stimulations. An additional follow-up will be conducted 4 weeks after the last stimulation. The first participant was enrolled on June 4, 2022. Study completion will be in December 2027. The project is approved by the Regional Ethical Committee of Medicine and Health Sciences, Northern Norway, project number 228765. The trial will be conducted according to Good Clinical Practice and published safety guidelines on rTMS treatment.DiscussionThe aims of the present trial are to investigate the antidepressive effect of a 10-session iTBS protocol on moderately depressed outpatients and to explore the factors that can explain the reduction in depressive symptoms after iTBS but also a poorer response to the treatment. In separate, but related work packages, the trial will assess how clinical, cognitive, brain imaging and genetic measures at baseline relate to the variability in the antidepressive effects of iTBS.Trial registrationClinicalTrials.gov NCT05516095. Retrospectively registered on August 25, 2022.

Project description:IntroductionRepetitive transcranial magnetic stimulation (rTMS) may have anti-epileptic effects, especially in patients with neocortical lesions. Initial clinical trials demonstrated that the duration of the seizure reducing effect is relatively short-lived. In the context of a chronic condition like epilepsy, theta burst stimulation (TBS) may represent a potential solution in optimizing treatment practicality and durability as it was demonstrated to be associated with longer-lasting after-effects. TBS has been studied extensively in diverse neuropsychiatric conditions, but a therapeutic TBS protocol has not previously been applied in epilepsy patients.Materials and methodsWe performed a prospective open-label pilot study of 4-day accelerated continuous TBS (cTBS) treatment in patients with neocortical drug-resistant epilepsy (DRE). A treatment session consisted of 5 cTBS trains, each comprising 600 pulses presented in 50 Hz triplet bursts every 200 ms, delivered at 10-min intertrain-intervals, targeted over the epileptic focus (EF) using a neuronavigation-guided figure-of-8 coil. Safety and feasibility, and seizure frequency were assessed as primary and secondary endpoints, respectively, over a 4-week baseline period, a 1-week treatment period and a 7-week follow-up period, using adverse event logging, electro-encephalography, cognitive, and psychological questionnaires and a seizure diary kept by the patients and/or caregivers.ResultsSeven subjects (4M:3F; median age 48, interquartile ranges 25) underwent the treatment protocol. Adverse events were reported in all subjects but were mild and transient. No clinical or electrographic seizures were evoked during or immediately following stimulation. No deterioration was found in cognition nor in psycho-emotional well-being following treatment. Treatment burden was acceptable, but seems to depend on clinical effect, duration of ongoing effect and stimulation site. Median weekly seizure frequency and ratio of seizure-free weeks did not change significantly in this small patient cohort.ConclusionWe report the results of the first ever trial of cTBS as a treatment for neocortical DRE. A 4-day accelerated cTBS protocol over the EF appears safe and feasible. Although the design and sample size of this open-label pilot study is unfit to reliably identify a therapeutic effect, results encourage further exploration of cTBS as an anti-epileptic treatment and potential optimization compared to conventional rTMS in a dedicated randomized controlled trial. (clinicaltrials.gov: NCT02635633).

Dataset Information

Continuous theta burst stimulation over the bilateral supplementary motor area in obsessive-compulsive disorder treatment: A clinical randomized single-blind sham-controlled trial.

Background

Objective

Methods

Results

Conclusions

Publications

Continuous theta burst stimulation over the bilateral supplementary motor area in obsessive-compulsive disorder treatment: A clinical randomized single-blind sham-controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets