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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Magnetic Stimulation I | Experimental | Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex |
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| Transcranial Magnetic Stimulation II | Experimental | Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex |
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| Sham Stimulation | Sham Comparator | Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| navigated rTMS of motor cortex | Device | Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eija Kalso, PhD, Prof. | Professor of Pain Research and Management, University of Helsinki. Director of the Multidisciplinary Pain Clinic, Department of Anaesthesia and Intensive Care Medicine Helsinki University Central Hospital | Principal Investigator |
| Jyrki Mäkelä, MD, PhD | Head of laboratory, BioMag, Helsinki University Central Hospital | Study Chair |
| Erika Kirveskari, MD, PhD | Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital | Study Chair |
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That is not allowed according to the ethical committees decision.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| navigated rTMS of somatosensory cortex 2 | Device | Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks |
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| SHAM rTMS with SHAM block | Device | Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks. |
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |