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 range18 Years – 80 Years

SexALL

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.
✕. 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.

What they're measuring

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: immediately before treatment 1

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: immediately after treatment 1

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: immediately before treatment 2

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: immediately after treatment 2

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: one-month follow-up

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: three-month follow-up

Trial details

NCT IDNCT05829005

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Functional Neurological Symptom Disorder trials

Who can participate

Age range18 Years – 80 Years

SexALL

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.
✕. 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.

What they're measuring

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: immediately before treatment 1

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: immediately after treatment 1

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: immediately before treatment 2

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: immediately after treatment 2

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: one-month follow-up

Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale

Timeframe: three-month follow-up