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

NCT ID: NCT02277912

Last Updated: 2018-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Central Post Stroke Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transcranial Magnetic Stimulation I

Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex

Group Type EXPERIMENTAL

navigated rTMS of motor cortex

Intervention Type DEVICE

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

Transcranial Magnetic Stimulation II

Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex

Group Type EXPERIMENTAL

navigated rTMS of somatosensory cortex 2

Intervention Type DEVICE

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

Sham Stimulation

Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex

Group Type SHAM_COMPARATOR

SHAM rTMS with SHAM block

Intervention Type DEVICE

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

Interventions

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navigated rTMS of motor cortex

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

Intervention Type 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

Intervention Type DEVICE

SHAM rTMS with SHAM block

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

Intervention Type DEVICE

Other Intervention Names

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Navigated rTMS Navigated rTMS Navigated rTMS Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Juhani Ojala

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eija Kalso, PhD, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Jyrki Mäkelä, MD, PhD

Role: STUDY_CHAIR

Head of laboratory, BioMag, Helsinki University Central Hospital

Erika Kirveskari, MD, PhD

Role: STUDY_CHAIR

Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital

Other Identifiers

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TYH2013311

Identifier Type: -

Identifier Source: org_study_id

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