Clinical Trial: TMS and Attentional Bias in Functional Motor Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: TMS and Attentional Bias in Functional Motor Disorder

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.


Detailed Summary:

A randomised non-blinded controlled study design will be used, with 3 months of treatment as usual as the control condition and a single session of TMS as the treatment condition.

40 patients with functional unilateral upper limb weakness will be recruited from neurology and neuropsychiatry clinics in Edinburgh and randomised to either immediate treatment or to 3 month delay during which they will receive routine clinical care. Randomisation will be performed using computerised random number generator by a person not involved with the study.

Patients randomised to delay will complete baseline measures of disability and motor function including SF36, modified Rankin score and study specific questionnaires, and will repeat these after 3 months. Patients undergoing immediate treatment will complete the same questionnaires immediately before and 3 months after treatment. All individuals receiving TMS treatment will undergo tests of grip strength and tapping frequency immediately before and after treatment.

The treatment and experiments involved will be as follows. Patients will attend the PPLS Cognitive Neuroscience Laboratory at George Square, University of Edinburgh for a single 2 hour session. During the first hour they will complete baseline symptom severity and disability questionnaires and will undertake a series of 3 experiments. Experiments involve participants sitting with their head on a chin-rest looking at either a computer screen or at lights projected onto their own hands, and for one experiment with a vibrating 'buzzer' taped to each hand. They will be asked to respond verbally in experiments which test their response to distracting attentional 'cues' either visual or vibrotactile. These experiments will take less than 1 hour. In anaylsis, performance will be com
Sponsor: University of Edinburgh

Current Primary Outcome:

  • Patient-rated disability [ Time Frame: An average of 3 months after day of attendance for TMS treatment. ]
    SF36 score and Modified Rankin Score
  • Patient rated symptom severity [ Time Frame: An average of 3 months after day of attendance for TMS treatment ]
    Assessed using a Likert scale.


Original Primary Outcome:

  • Patient-rated disability [ Time Frame: 3 months after treatment ]
    SF36 score and Modified Rankin Score
  • Patient rated symptom severity [ Time Frame: 3 months after treatment ]
    Assessed using a Likert scale.


Current Secondary Outcome:

  • Grip strength [ Time Frame: Between 10 minutes and one hour before TMS treatment, and between 10 minutes and 1 hour after TMS treatment. ]
  • Hand tapping frequency [ Time Frame: Between 10 minutes and one hour before TMS treatment, and between 10 minutes and 1 hour after TMS treatment ]
  • Patient rated treatment discomfort [ Time Frame: Between 10 minutes and 1 hour after TMS treatment. ]


Original Secondary Outcome:

  • Grip strength [ Time Frame: Immediately before and after treatment ]
  • Hand tapping frequency [ Time Frame: Immediately before and after treatment. ]
  • Patient rated treatment discomfort [ Time Frame: Immediately after treatment ]


Information By: University of Edinburgh

Dates:
Date Received: March 31, 2014
Date Started: October 2014
Date Completion:
Last Updated: February 8, 2016
Last Verified: December 2014