Neurostimulation treatment for functional motor symptoms
Trial of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study
This study is testing if a special brain stimulation treatment can help improve movement problems in people with functional neurological disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05829005 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the efficacy of single-pulse transcranial magnetic stimulation (TMS) over the motor cortex in improving symptoms of functional neurological disorder (FND). It employs a randomized, double-blind, parallel-arm design to minimize bias and ensure reliable results. Participants will be randomly assigned to either an active TMS treatment group or an inactive control group, with the aim of assessing both the treatment's effectiveness and potential predictors of response. The study also seeks to explore the mechanisms of action behind TMS in treating motor symptoms associated with FND.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with motor functional neurological disorder by a qualified neurologist or neuropsychiatrist.
Not a fit: Patients with epilepsy, other significant neurological conditions, or major mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from functional neurological disorder.
How similar studies have performed: While this approach is novel in the context of functional neurological disorder, similar studies using TMS for other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. 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. 2. Age ≥18yrs. 3. Ability to give written informed consent. Exclusion Criteria 1. Epilepsy (or considered high risk of epilepsy from medical history). 2. Other contraindication to TMS (e.g. cochlear implants, metallic intracranial clips/surgery in last 12 months). 3. Comorbid organic neurological condition. 4. Pain as primary symptom. 5. Previous treatment with TMS (for any condition). 6. Non-fluent English speakers (if unable to accurately complete self-report questionnaires). 7. Major mental health disorder: current diagnosis of schizophrenia or bipolar disorder; current drug/alcohol dependence. 8. History of factitious disorder. 9. Currently involved in another trial. 10. Pregnancy
Where this trial is running
London
- Institute of Psychiatry, Psychology & Neuroscience — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Timothy Nicholson, MBBS, PhD — King's College London
- Study coordinator: Timothy Nicholson, MBBS, PhD
- Email: timothy.nicholson@kcl.ac.uk
- Phone: 0207 848 5136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.