Trial of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study

King's College London1 个研究点分布在 1 个国家目标入组 51 人开始时间: 2023年8月1日最近更新: 2026年2月2日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: King's College London
入组人数: 51
试验地点: 1
主要终点: Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A pilot randomised controlled trial (RCT) of single-pulse transcranial magnetic stimulation (TMS) over the motor cortex to investigate efficacy in improving motor FND symptoms and to make a preliminary investigation of predictors of response to TMS and potential mechanisms of action.

详细描述

This study is a pilot trial that will aim to determine if Transcranial Magnetic Stimulation (TMS) is an effective, tolerated and safe treatment for functional neurological disorder (FND) and to make a preliminary investigation of predictors of response to TMS and potential mechanisms of action.

This trial will be a 'randomised, two-arm, double-blind, parallel-arm study design. Randomised means that patients will be allocated to 'active' or 'inactive' treatment groups at random - this is done to minimise the chances of the characteristics of groups being different and influencing response to the different treatments. Double-blind means that the patients will not know which group they have been allocated to, and the assessors of response to treatment will be blinded, which will help reduce researcher 'bias' in assessing response. Parallel means that the treatment groups will occur alongside each other and patients will only have one of the treatments during the trial - unlike a 'crossover' design where patients will get both. However, after the trial, if a patient has received the 'inactive' treatment they will be offered the 'active' treatment if, after review by the clinician, such treatment is considered appropriate by the clinician.

The 'active' intervention is supra-threshold TMS that is so-called as it above the threshold needed to stimulate the primary motor cortex, the area of the brain known as 'M1' that when stimulated leads to contraction of limb muscles and can therefore make a weak limb move that the patient would otherwise not be able to move. This study postulates that it is the stimulation of a paralysed limb resulting in movement that is the active component of treatment, as it allows patients to relearn and re-experience normal movement, as well as providing proof of the possibility of the return of function.

An 'inactive' control arm is being used in this study as this is the standard way to show if, and how much, any response to the 'active' intervention might be due to chance. The investigators will be using sub-threshold TMS, so real TMS that will stimulate the motor cortex. This is different to other options for the control arm, such 'sham' TMS where no actual TMS pulse is delivered. Such sham devices deliver a similar sensation to the scalp and are designed to look the same as 'real' TMS devices so it is hard, and ideally impossible, for the patient to know whether they were getting real or sham treatment. This will also be delivered to the same location (primary motor cortex, ie. 'M1'). The location and number of pulses have been set at the same as the active treatment. The intensity of stimulation will necessarily be less, but will still result in a stimulus that is felt by the subject to maximise chances of successful blinding.

Importantly, and necessarily, details of what the two arms will involve are kept vague in the information sheet to maximise the chances of successful blinding of participants. There is genuine equipoise between these two proposed arms because, as yet, there is no evidence that the reported effects of TMS in the published case series are anything other than placebo. The one published feasibility RCT found no significant increase in subjective ratings of strength compared to placebo.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of motor FND (i.e. presenting with weakness of at least one limb) made by consultant neurologist and/or neuropsychiatrist.
•Age ≥18yrs.
•Ability to give written informed consent.

排除标准

•Epilepsy (or considered high risk of epilepsy from medical history).
•Other contraindication to TMS (e.g. cochlear implants, metallic intracranial clips/surgery in last 12 months).
•Comorbid organic neurological condition.
•Pain as primary symptom.
•Previous treatment with TMS (for any condition).
•Non-fluent English speakers (if unable to accurately complete self-report questionnaires).
•Major mental health disorder: current diagnosis of schizophrenia or bipolar disorder; current drug/alcohol dependence.
•History of factitious disorder.
•Currently involved in another trial.

研究组 & 干预措施

Active arm

Active Comparator

The location and number of pulses will be set. The intensity of stimulation will be felt by the subject. 120 stimuli - including at least 20 supra (motor) threshold stimuli causing movement of the affected limb.

干预措施: Transcranial magnetic stimulation (TMS) (Device)

Inactive/control arm

Sham Comparator

The location and number of pulses have been set at the same as the active treatment. The intensity of stimulation will necessarily be less but will still result in a stimulus that is felt by the subject to maximise chances of successful blinding. 120 stimuli - no stimuli of sufficient intensity to produce movement.

干预措施: Transcranial magnetic stimulation (TMS) (Device)