Conversion DisorderNCT02102906
TMS and Attentional Bias in Functional Motor Disorder
A study testing Transcranial magnetic stimulation in people with Conversion Disorder, run by University of Edinburgh at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Conversion Disorder
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- difficulties in understanding spoken or written English
- history of epileptic seizures (non-epileptic seizures will not be an exclusion criteria)
- alcohol dependence
- severe co-morbid physical or psychiatric disorder
- factitious disorder
- patients unable to receive TMS because of metal implants such as pacemakers
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Clinical Neurosciences, Western General Hospital
Edinburgh, Scotland, EH4 2XU
Department of Psychology, University of Edinburgh
Edinburgh, Scotland, EH8 9AD
About this study
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.
Read the detailed description
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 compared between affected and unaffected sides (ie left hand and right hand), and will also be compared with performance of a group of 15 healthy control participants recruited from spouses or partners.
Patient participants will then receive treatment with 20 single pulses of TMS to the motor cortex at 120% motor threshold. These will cause visible and palpable 'jerks' of the affected limb. Between stimulations the researcher will offer verbal encouragement and ask the participant to move the affected limb if possible. Treatment will take less than 1 hour.
The primary outcome measures are patient-rated symptom severity and disability and simple statistical analysis will be used to compare outcome after 3 months of treatment as normal and 3 months after a single session of TMS treatment. Secondary outcome measures include grip strength and tapping frequency before and after treatment. Data will be analysed on an intention-to-treat basis. Data from attentional tests will be analysed separately.
- Conditions
- Conversion Disorder
- Being tested
- Transcranial magnetic stimulation
- Keywords
- Adult, Humans, Conversion disorder, Somatoform Disorders/therapy, Nervous System Disorders/therapy
- Medical subject headings
- Conversion Disorder, Somatoform Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated disability
SF36 score and Modified Rankin Score
Measured: An average of 3 months after day of attendance for TMS treatment.
Patient rated symptom severity
Assessed using a Likert scale.
Measured: An average of 3 months after day of attendance for TMS treatment
Secondary outcomes (3)
Grip strength
Measured: Between 10 minutes and one hour before TMS treatment, and between 10 minutes and 1 hour after TMS treatment.
Hand tapping frequency
Measured: Between 10 minutes and one hour before TMS treatment, and between 10 minutes and 1 hour after TMS treatment
Patient rated treatment discomfort
Measured: Between 10 minutes and 1 hour after TMS treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conversion DisorderStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Stone, MBChB PhD FRCP, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102906
- Sponsor's protocol ID
- TMS
- Status last verified
- Dec 2014
- First submitted
- 31 Mar 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27663118
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS and Attentional Bias in Functional Motor Disorder
- ClinicalTrials.gov ID
- NCT02102906
- Acronym / sponsor ID
- TMS
- Conditions
- Conversion Disorder
- Keywords
- Adult, Humans, Conversion disorder, Somatoform Disorders/therapy, Nervous System Disorders/therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 compared between affected and unaffected sides (ie left hand and right hand), and will also be compared with performance of a group of 15 healthy control participants recruited from spouses or partners.
Patient participants will then receive treatment with 20 single pulses of TMS to the motor cortex at 120% motor threshold. These will cause visible and palpable 'jerks' of the affected limb. Between stimulations the researcher will offer verbal encouragement and ask the participant to move the affected limb if possible. Treatment will take less than 1 hour.
The primary outcome measures are patient-rated symptom severity and disability and simple statistical analysis will be used to compare outcome after 3 months of treatment as normal and 3 months after a single session of TMS treatment. Secondary outcome measures include grip strength and tapping frequency before and after treatment. Data will be analysed on an intention-to-treat basis. Data from attentional tests will be analysed separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS treatment | Experimental | Procedure: Transcranial magnetic stimulationPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- difficulties in understanding spoken or written English
- history of epileptic seizures (non-epileptic seizures will not be an exclusion criteria)
- alcohol dependence
- severe co-morbid physical or psychiatric disorder
- factitious disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationSingle 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. | Procedure or surgery | TMS treatment |
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.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Derived from this study: PubMed 27663118McWhirter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Stone, MBChB PhD FRCP principal investigator
NHS Lothian
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Conversion Disorder, run by University of Edinburgh at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-rated disability (time frame: An average of 3 months after day of attendance for TMS treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.