Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)
- Conditions
- Central Post Stroke Pain
- Interventions
- Device: SHAM rTMS with SHAM blockDevice: navigated rTMS of motor cortexDevice: navigated rTMS of somatosensory cortex 2
- Registration Number
- NCT02277912
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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
- Epilepsy
- Difficult aphasia
- Dementia
- Contraindication for TMS or MRI
- Alcohol and/or drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sham Stimulation SHAM rTMS with SHAM block Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex Transcranial Magnetic Stimulation I navigated rTMS of motor cortex Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex Transcranial Magnetic Stimulation II navigated rTMS of somatosensory cortex 2 Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex
- Primary Outcome Measures
Name Time Method Change in average pain compared to baseline 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.
- Secondary Outcome Measures
Name Time Method Quality of life (EQ-5D) One week after each arm of the study and 6 months after the last one Questionnaire EQ-5D
Depression One week after each arm of the study and 6 months after the last stimulation Questionnaire
Change in average pain compared to baseline 2,3,4,5 and 6 months after the last stimulation Phone call ( Numeric Rating Scale (NRS) in rest and movement )
Magnetoencephalography (MEG) 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 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 One week before and after each arm of the study Nine hole peg, Pinch and Jamar
Cold water test One week before and after each arm of the study Conditioned pain modulation (CPM)
Genetics No time frame, just a blood sample Evaluation of genetical properties in terms of TMS related pain reduction