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

October 22, 2018 updated by: Juhani Ojala, Helsinki University Central Hospital

Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • rTMS
  • Navigated
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
Other Names:
  • rTMS
  • Navigated
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.
Other Names:
  • Placebo
  • rTMS
  • Navigated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month after each arm of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One week after each arm of the study and 6 months after the last one
Depression
Time Frame: One week after each arm of the study and 6 months after the last stimulation
Questionnaire
One week after each arm of the study and 6 months after the last stimulation
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 )
2,3,4,5 and 6 months after the last stimulation
Magnetoencephalography (MEG)
Time Frame: One week before and after each arms stimulations
Changes in the irritability of the motor cortex and somatosensory cortex
One week before and after each arms stimulations
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
From the start to the end of the study, on average 12 months per patient.
Hands´ motor function and dexterity
Time Frame: One week before and after each arm of the study
Nine hole peg, Pinch and Jamar
One week before and after each arm of the study
Cold water test
Time Frame: One week before and after each arm of the study
Conditioned pain modulation (CPM)
One week before and after each arm of the study
Genetics
Time Frame: No time frame, just a blood sample
Evaluation of genetical properties in terms of TMS related pain reduction
No time frame, just a blood sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYH2013311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

That is not allowed according to the ethical committees decision.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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