Trial Of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a … (NCT05829005) | Clinical Trial Compass
CompletedNot Applicable
Trial Of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study
United Kingdom51 participantsStarted 2023-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Timeframe: immediately before treatment 1
2
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Timeframe: immediately after treatment 1
3
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Timeframe: immediately before treatment 2
4
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Timeframe: immediately after treatment 2
5
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Timeframe: one-month follow-up
6
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale