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

Helsinki University Central Hospital21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Central Post Stroke Pain

Interventions

navigated rTMS of motor cortexDEVICE

Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.

navigated rTMS of somatosensory cortex 2DEVICE

Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks

SHAM rTMS with SHAM blockDEVICE

Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 month after each arm of the study

Secondary Outcomes

Quality of life (EQ-5D)

Questionnaire EQ-5D

Time frame: One week after each arm of the study and 6 months after the last one

Depression

Questionnaire

Time frame: 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 )

Time frame: 2,3,4,5 and 6 months after the last stimulation

Magnetoencephalography (MEG)

Changes in the irritability of the motor cortex and somatosensory cortex

Time frame: One week before and after each arms stimulations

Number of patients with adverse effects

Adverse effects are followed actively

Time frame: 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

Time frame: One week before and after each arm of the study

Cold water test

Conditioned pain modulation (CPM)

Data from ClinicalTrials.gov

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