Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)

Study Overview
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Brief Summary
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The aim of the study is to evaluate the analgesic effects of navigated repetitive transcranial magnetic stimulation in central post stroke pain. MRI based navigation is used to determine the exact locations for stimulation.

Detailed Description
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Central post stroke pain is often very resistant to treatment. TMS has been shown to be a promising tool in treating difficult pain conditions. The best sites for stimulation are still not known and navigation has been used only in few studies. The aim is to evaluate the analgesic effects of Navigated Repetitive Transcranial Magnetic Stimulation ( nrTMS ) on pain in a three armed crossover study. The navigation is done by using magnetic resonance imaging and stereotactic camera system. The three arms include stimulation to M1, S2 and sham stimulation to M1. 10 Hz repetitive stimulation is given to a specified location once a day 5 days a week for two weeks in each of the three arms. A months washout period is kept between each arm of the study. Pain and other variables are followed before, during and after the study for 6 months.

Official Title
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Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain

Conditions
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Central Post Stroke Pain

Intervention / Treatment
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* Device: navigated rTMS of motor cortex
* Device: navigated rTMS of somatosensory cortex 2
* Device: SHAM rTMS with SHAM block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MRI defined brain infarction or hemorrhage before or at the age of 65 years CPSP diagnostic criteria is met (definite), verified by a neurologist Stable analgesic medication Average pain NRS 4 or more Exclusion Criteria: Epilepsy Difficult aphasia Dementia Contraindication for TMS or MRI Alcohol and/or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Magnetic Stimulation I<br>Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex | Device: navigated rTMS of motor cortex<br>* Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.<br>* Other names: rTMS;|
| Experimental: Transcranial Magnetic Stimulation II<br>Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex | Device: navigated rTMS of somatosensory cortex 2<br>* Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks<br>* Other names: rTMS;|
| Sham Comparator: Sham Stimulation<br>Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex | Device: SHAM rTMS with SHAM block<br>* Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average pain compared to baseline | Patients will keep a pain diary for one week before stimulation and for two weeks after the stimulation. A nurse will call the patient one month after the last stimulation. | 1 month after each arm of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (EQ-5D) | Questionnaire EQ-5D | One week after each arm of the study and 6 months after the last one | 
| Depression | Questionnaire | One week after each arm of the study and 6 months after the last stimulation | 
| Change in average pain compared to baseline | Phone call ( Numeric Rating Scale (NRS) in rest and movement ) | 2,3,4,5 and 6 months after the last stimulation | 
| Magnetoencephalography (MEG) | Changes in the irritability of the motor cortex and somatosensory cortex | One week before and after each arms stimulations | 
| Number of patients with adverse effects | Adverse effects are followed actively | From the start to the end of the study, on average 12 months per patient. | 
| Hands´ motor function and dexterity | Nine hole peg, Pinch and Jamar | One week before and after each arm of the study | 
| Cold water test | Conditioned pain modulation (CPM) | One week before and after each arm of the study | 
| Genetics | Evaluation of genetical properties in terms of TMS related pain reduction | No time frame, just a blood sample | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICH, Stroke, Navigated, Placebo, TMS