Clinical trial NCT02277912: Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)
Official title: Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Post Stroke Pain
Keywords: ICH
Stroke
Navigated
Placebo
TMS
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in average pain compared to baseline
timeFrame: 1 month after each arm of the study
Secondary outcomes:
measure: Quality of life (EQ-5D)
timeFrame: One week after each arm of the study and 6 months after the last one
measure: Depression
timeFrame: One week after each arm of the study and 6 months after the last stimulation
measure: Change in average pain compared to baseline
timeFrame: 2,3,4,5 and 6 months after the last stimulation
measure: Magnetoencephalography (MEG)
timeFrame: One week before and after each arms stimulations
measure: Number of patients with adverse effects
timeFrame: From the start to the end of the study, on average 12 months per patient.
measure: Hands´ motor function and dexterity
timeFrame: One week before and after each arm of the study
measure: Cold water test
timeFrame: One week before and after each arm of the study
measure: Genetics
timeFrame: No time frame, just a blood sample
Other outcomes:
Locations:
Study officials:
affiliation: 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
name: Eija Kalso, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of laboratory, BioMag, Helsinki University Central Hospital
name: Jyrki Mäkelä, MD, PhD
role: STUDY_CHAIR
affiliation: Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital
name: Erika Kirveskari, MD, PhD
role: STUDY_CHAIR
References: