Condition category
Nervous System Diseases
Date applied
18/09/2017
Date assigned
02/10/2017
Last edited
02/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Conversion disorder (CD), also known as Functional Neurological Disorder (FND) is where neurological symptoms, such as weakness, occur but no structural neurological disease can be found – therefore they are disorders of function, rather than structure. There are few proven treatments for weakness that is caused by CD. There is encouraging preliminary evidence that Transcranial Magnetic Stimulation (TMS) could be an effective and safe treatment for such symptoms. This is a noninvasive procedure that uses magnetic fields to stimulate nerves in the brain. However, this treatment requires a randomization controlled trial to establish whether this is could be a treatment. The aim of this study is to examine if TMS can be a new treatment for CD.

Who can participate?
Adults aged 18 and older who have a motor conversion disorder.

What does the study involve?
Participants who are suitable for this study are randomly allocated to one of two groups. Those in the first group receive the active treatment and those in the second group receive in the inactive treatment. Participants attend two treatment sessions, separated by one month. Each TMS treatment session takes around 30 minutes. Some tests and questionnaires are completed before and after each TMS session, to assess current symptoms and health. In total, each treatment session will take around 1.5 hours. Two months after the first treatment session, participants are invited to attend a final follow-up session, during which several questionnaires and a short examination will be completed, but no additional TMS treatment will be delivered.

What are the possible benefits and risks of participating?
The main benefit to taking part is the potential to improve understanding about treatments that are effective for people with weakness caused by conversion disorder. There are some risks to taking part in the study as TMS can, in some cases, cause side effects including discomfort around the area it is delivered to (the scalp), headaches, and seizures. These side effects are relatively uncommon, particularly at low doses of TMS, such as that used in this trial. It is, however, also possible that some of the questionnaires might cause distress as they ask about psychological symptoms and potentially traumatic life events. Appropriate support will be provided to patients who disclose any significant distress or side effects during the study.

Where is the study run from?
King's College London (UK)

When is the study starting and how long is it expected to run for?
June 2014 to March 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Tim Nicholson

Trial website

Contact information

Type

Public

Primary contact

Dr Tim Nicholson

ORCID ID

http://orcid.org/0000-0002-2350-2332

Contact details

King's College London
Section of Cognitive Neuropsychiatry (PO68)
Institute of Psychiatry Psychology & Neuroscience
De Crespigny Park
London
SE58AF
United Kingdom
+44 207 848 5136
timothy.nicholson@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v1.0

Study information

Scientific title

Trial Of Neurostimulation In Conversion Symptoms (TONICS) feasibility study

Acronym

TONICS feasibility

Study hypothesis

Transcranial Magnetic Stimulation (TMS) is more effective than placebo in improving weakness in motor conversion (functional neurological) disorder.

Ethics approval

London - Stanmore Research Ethics Committee, 12/06/2017, ref: 17/LO/0410

Study design

Single-centre, single-blind, placebo-controlled parallel trial feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Motor conversion (functional neurological) disorder

Intervention

Participants are initially provided with a detailed information sheet and have time to consider participation and to ask questions. Once a patient has provided written informed consent, they attend an initial baseline appointment (approx. 1.5 hours) during which a research associate collects relevant background details about the patient (e.g., demographic details, psychological symptoms, medical history). A careful assessment of the safety of TMS for each individual is also completed during the baseline visit.

Patients diagnosed with motor conversion disorder (functional weakness of at least one limb) are randomised to one of two treatment arms using a computerised randomisation system. The treatment arms are active and inactive Transcranial Magnetic Stimulation (TMS). Both treatment arms involves single pulse TMS being delivered to primary motor cortex in both hemispheres. A total of 120 pulses are delivered during each of the two treatment sessions, which are one month apart. TMS is delivered by a suitably trained neurophysiologist or neuropsychiatrist. All TMS delivery takes in specialist TMS laboratories.

The aims are to investigate the feasibility of a trial of the above intervention.

Participants attend four sessions in total. One initial baseline assessment, two treatment sessions and a follow-up session. TMS session 1 takes place 0-14 days after baseline, TMS session 2 approximately one month after TMS session 1, and follow-up approximately three months after TMS session 1.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Patient reported changes in symptoms measured using the patient-rated Clinical Global Impression of Improvement scale (CGI-I) at TMS session 1, TMS session 2 and at follow-up.

Secondary outcome measures

1. Assessor-rated symptom change measured using clinician-rated Clinical Global Impression of Improvement scale (CGI-I) at TMS session 1, TMS session 2 and follow-up
2. Disability and activities of daily living measured using functional rating scales: SF-36, Barthel, FIM/FAM at TMS session 1, TMS session 2 and follow-up
3. Current symptom severity measured using objective and subjective measures of strength: dynamometry and patient ratings at TMS session 1, TMS session 2 and follow-up
4. Current psychological symptoms measured using self-report questionnaires: GAD7, PHQ9, PHQ15 and CORE-10 at TMS session 1, TMS session 2 and at follow-up
5. Psychosocial outcomes measured with a self-report questionnaire: Work and Social Adjustment Scale at TMS session 1, TMS session 2 and at follow-up
6. Health economics measured using the Client Service Receipt Inventory at TMS session 1, TMS session 2 and at follow-up

Overall trial start date

01/06/2014

Overall trial end date

29/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. DSM5 diagnosis of motor conversion disorder made by consultant neurologist and/or neuropsychiatrist, causing weakness of at least one limb
2. Age ≥18 years
3. Ability to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant 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 or intracranial 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 +/- previous diagnosis of schizophrenia or bipolar disorder; current drug/alcohol dependence
8. History of factitious disorder
9. Currently involved in another trial

Recruitment start date

03/10/2017

Recruitment end date

29/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
Neurophysiology Department Fourth floor Ruskin Wing King’s College Hospital Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Room 1.8
Hodgkin Building
Guy’s Campus
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trial will be published in a high-impact peer-reviewed journal.

IPD Sharing statement:
Participant level data is not expected to be made available as it is not deemed necessary to do so for a feasibility study and we did not request ethical approval to publish these data. These data will be held at the host department (Section of Cognitive Neuropsychiatry, Institute of Psychiatry Psychology & Neuroscience, King’s College London).

Intention to publish date

01/07/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes