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

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ClinicalTrials.gov Identifier: NCT02277912
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Juhani Ojala, Helsinki University Central Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Central Post Stroke Pain Device: navigated rTMS of motor cortex Device: navigated rTMS of somatosensory cortex 2 Device: SHAM rTMS with SHAM block Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain
Study Start Date : May 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016
Arms and Interventions
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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:
  • Navigated
  • rTMS
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:
  • Navigated
  • rTMS
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:
  • Navigated
  • rTMS
  • Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Depression [ Time Frame: One week after each arm of the study and 6 months after the last stimulation ]
    Questionnaire

  3. 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 )

  4. Magnetoencephalography (MEG) [ Time Frame: One week before and after each arms stimulations ]
    Changes in the irritability of the motor cortex and somatosensory cortex

  5. 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

  6. Hands´ motor function and dexterity [ Time Frame: One week before and after each arm of the study ]
    Nine hole peg, Pinch and Jamar

  7. Cold water test [ Time Frame: One week before and after each arm of the study ]
    Conditioned pain modulation (CPM)

  8. Genetics [ Time Frame: No time frame, just a blood sample ]
    Evaluation of genetical properties in terms of TMS related pain reduction


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277912


Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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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
More Information
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Responsible Party: Juhani Ojala, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02277912    
Other Study ID Numbers: TYH2013311
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: That is not allowed according to the ethical committees decision.
Keywords provided by Juhani Ojala, Helsinki University Central Hospital:
ICH
Stroke
Navigated
Placebo
TMS
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases