NCT02102906

Brief Summary

Functional motor disorders, also called motor conversion disorder, are common reasons for attendance at neurology outpatient clinics. Patients with functional motor disorders are more common than patients with multiple sclerosis and have similar levels of disability but more psychological morbidity. There is limited evidence for effective treatments in functional motor disorders. A small number of studies of transcranial magnetic stimulation (TMS), a painless method of cortical stimulation, have reported improvement in functional weakness after this treatment including in patients with symptoms of several years duration. The Investigators intend to trial TMS in a group of 40 patients with functional motor disorder, randomising patients to immediate or delayed treatment and therefore comparing a single session of TMS with routine clinical care. The Investigators will also ask patients to undergo tests of attentional focus in a cognitive neuroscience laboratory - these experiments will be analysed separately from TMS trial data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 9, 2016

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

March 31, 2014

Last Update Submit

February 8, 2016

Conditions

Conversion Disorder

Keywords

AdultHumansConversion disorderSomatoform Disorders/therapyNervous System Disorders/therapy

Outcome Measures

Primary Outcomes (2)

  • Patient-rated disability

    SF36 score and Modified Rankin Score

    An average of 3 months after day of attendance for TMS treatment.

  • Patient rated symptom severity

    Assessed using a Likert scale.

    An average of 3 months after day of attendance for TMS treatment

Secondary Outcomes (3)

  • Grip strength

    Between 10 minutes and one hour before TMS treatment, and between 10 minutes and 1 hour after TMS treatment.

  • Hand tapping frequency

    Between 10 minutes and one hour before TMS treatment, and between 10 minutes and 1 hour after TMS treatment

  • Patient rated treatment discomfort

    Between 10 minutes and 1 hour after TMS treatment.

Other Outcomes (1)

  • Attentional focus / distractibility

    Tests performed during the 1-2 hours before treatment.

Study Arms (1)

TMS treatment

EXPERIMENTAL

Patients will receive a single session of 20 single pulses of TMS to motor cortex contralateral to affected upper limb at 120% motor threshold, with verbal encouragement throughout. Half of the patients recruited will be randomised to a 3 month delay during which they will receive treatment as normal.

Procedure: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationPROCEDURE

Single pulse TMS - 20 pulses at 120% motor threshold. Using the Magstim rapid 2 stimulator, which has a CE mark and will be used within the indications specified by the CE mark.

TMS treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis, by a consultant neurologist, of functional motor disorder
  • functional unilateral upper limb weakness present for 50% or more of the time
  • age 18-75
  • ability to give informed consent

You may not qualify if:

  • difficulties in understanding spoken or written English
  • alcohol dependence
  • severe co-morbid physical or psychiatric disorder
  • factitious disorder
  • patients unable to receive TMS because of metal implants such as pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Clinical Neurosciences, Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Department of Psychology, University of Edinburgh

Edinburgh, Scotland, EH8 9AD, United Kingdom

Location

Related Publications (1)

  • McWhirter L, Ludwig L, Carson A, McIntosh RD, Stone J. Transcranial magnetic stimulation as a treatment for functional (psychogenic) upper limb weakness. J Psychosom Res. 2016 Oct;89:102-6. doi: 10.1016/j.jpsychores.2016.08.010. Epub 2016 Aug 25.

    PMID: 27663118DERIVED

MeSH Terms

Conditions

Conversion DisorderSomatoform DisordersNervous System Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jon Stone, MBChB PhD FRCP

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 9, 2016

Record last verified: 2014-12

Locations

GB(2)