TONICS pilot study
Research type
Research Study
Full title
TRIAL OF NEUROSTIMULATION TREATMENT AND INVESTIGATION FOR CAUSES OF FUNCTIONAL MOTOR SYMPTOMS (TONICS): A PILOT STUDY
IRAS ID
250915
Contact name
Timothy R J Nicholson
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
years, 18 months, days
Research summary
Functional Neurological Disorder (FND), also now known as a conversion disorder, is where neurological symptoms aren’t caused by neurological disease and are presumed to be psychological in origin. The symptoms are most commonly physical weakness (known as ‘motor’ FND), altered sensation or seizures. Little is known about how and why FND occurs and there are limited neurophysiological mechanisms and no proven treatments for motor FND.
An increasing number of case reports suggest that Transcranial Magnetic Stimulation (TMS), where a magnet is placed over the scalp to stimulate the underlying nerves controlling the affected limb, might be an effective treatment. However, until a randomized controlled trial (RCT) is done it cannot be established that TMS really is an effective and safe treatment that should be rolled out into clinical practice. Following a successful first feasibility study ('TONICS feasibility'), which tested whether the research protocol and design are feasible, this next stage ‘pilot' study will (1) address whether TMS is both effective and safe as a treatment for motor FND; (2) examine whether there are specific predictors of treatment response to TMS in people with motor FND; and (3) investigate neurophysiological profiles of FND compared to organic weakness and healthy control.
This study has 2 parts: The first part aims to compare responses from the ‘active’ TMS treatment with 'inactive' treatment. We will recruit participants diagnosed with motor FND and assess neuropsychological profiles and other biomarkers after TMS. The second part will be done concurrently with the first part. It aims to examine neurophysiological profiles and other biomarkers of FND by comparing participants with motor FND and participants with organic weakness and healthy control. Participants of both parts will be screened by inclusion and exclusion criteria. This study will be conducted at NHS sites. It will last for 18 months.
REC name
West of Scotland REC 4
REC reference
22/WS/0110
Date of REC Opinion
11 Nov 2022
REC opinion
Further Information Favourable Opinion