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

NCT05829005 | Completed

• 1 other identifier: 250915
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Neurological Symptom Disorder

Keywords

Functional neurological disorder

Outcome Measures

Primary Outcomes (6)

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

  Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.

  immediately before treatment 1

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

  Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.

  immediately after treatment 1

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

  Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.

  immediately before treatment 2

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

  Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.

  immediately after treatment 2

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

  Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.

  one-month follow-up

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

  Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.

  three-month follow-up

Secondary Outcomes (76)

• Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale

  immediately before treatment 1

• Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale

  immediately after treatment 1

• Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale

  immediately before treatment 2

• Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale

  immediately after treatment 2

• Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale

  one-month follow-up

Study Arms (2)

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.

Device: Transcranial magnetic stimulation (TMS)

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.

Device: Transcranial magnetic stimulation (TMS)

Interventions

Transcranial magnetic stimulation (TMS) DEVICE

TMS is a form of 'non-invasive brain stimulation', i.e. it is a way of stimulating the brain from outside the head. It works by holding a magnetic coil approximately the size of a small side plate against the head (it rests on the scalp) which then delivers magnetic pulses that stimulate the underlying brain. It was developed over 30 years ago and has been increasingly used to treat a number of neurological and psychiatric disorders. It is considered a relatively safe and generally well-tolerated treatment.

Active arm; Inactive/control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy

Sponsors & Collaborators

• King's College London: lead
• King's College Hospital NHS Trust: collaborator
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

Institute of Psychiatry, Psychology & Neuroscience

London, London, se5 8af, United Kingdom

Location

MeSH Terms

Conditions

Conversion Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Timothy Nicholson, MBBS, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centre, two-arm (active TMS, inactive TMS), double-blind (outcome assessor, patient), parallel-group RCT. Patients and researchers rating outcomes will be blind to the treatment arm, but it is not possible to blind the (different) researcher who is administering the treatments. There will be two treatment sessions, between 4-20 days apart, and two follow-up assessments one and three months after the first treatment session.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: April 25, 2023
• Study Start: August 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)