Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)
|ClinicalTrials.gov Identifier: NCT02277912|
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Central Post Stroke Pain||Device: navigated rTMS of motor cortex Device: navigated rTMS of somatosensory cortex 2 Device: SHAM rTMS with SHAM block||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Transcranial Magnetic Stimulation I
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex
Device: navigated rTMS of motor cortex
Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
Experimental: Transcranial Magnetic Stimulation II
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex
Device: navigated rTMS of somatosensory cortex 2
Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks
Sham Comparator: Sham Stimulation
Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex
Device: SHAM rTMS with SHAM block
Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
- Change in average pain compared to baseline [ Time Frame: 1 month after each arm of the study ]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.
- Quality of life (EQ-5D) [ Time Frame: One week after each arm of the study and 6 months after the last one ]Questionnaire EQ-5D
- Depression [ Time Frame: One week after each arm of the study and 6 months after the last stimulation ]Questionnaire
- Change in average pain compared to baseline [ Time Frame: 2,3,4,5 and 6 months after the last stimulation ]Phone call ( Numeric Rating Scale (NRS) in rest and movement )
- Magnetoencephalography (MEG) [ Time Frame: One week before and after each arms stimulations ]Changes in the irritability of the motor cortex and somatosensory cortex
- Number of patients with adverse effects [ Time Frame: From the start to the end of the study, on average 12 months per patient. ]Adverse effects are followed actively
- Hands´ motor function and dexterity [ Time Frame: One week before and after each arm of the study ]Nine hole peg, Pinch and Jamar
- Cold water test [ Time Frame: One week before and after each arm of the study ]Conditioned pain modulation (CPM)
- Genetics [ Time Frame: No time frame, just a blood sample ]Evaluation of genetical properties in terms of TMS related pain reduction
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277912
|Principal Investigator:||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|
|Study Chair:||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|