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

Primary Purpose

Central Post Stroke Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
navigated rTMS of motor cortex
navigated rTMS of somatosensory cortex 2
SHAM rTMS with SHAM block
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Post Stroke Pain focused on measuring ICH, Stroke, Navigated, Placebo, TMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Transcranial Magnetic Stimulation I

    Transcranial Magnetic Stimulation II

    Sham Stimulation

    Arm Description

    Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Quality of life (EQ-5D)
    Questionnaire EQ-5D
    Depression
    Questionnaire
    Change in average pain compared to baseline
    Phone call ( Numeric Rating Scale (NRS) in rest and movement )
    Magnetoencephalography (MEG)
    Changes in the irritability of the motor cortex and somatosensory cortex
    Number of patients with adverse effects
    Adverse effects are followed actively
    Hands´ motor function and dexterity
    Nine hole peg, Pinch and Jamar
    Cold water test
    Conditioned pain modulation (CPM)
    Genetics
    Evaluation of genetical properties in terms of TMS related pain reduction

    Full Information

    First Posted
    October 22, 2014
    Last Updated
    October 22, 2018
    Sponsor
    Helsinki University Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02277912
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Post Stroke Pain
    Keywords
    ICH, Stroke, Navigated, Placebo, TMS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transcranial Magnetic Stimulation I
    Arm Type
    Experimental
    Arm Description
    Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex
    Arm Title
    Transcranial Magnetic Stimulation II
    Arm Type
    Experimental
    Arm Description
    Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex
    Arm Title
    Sham Stimulation
    Arm Type
    Sham Comparator
    Arm Description
    Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex
    Intervention Type
    Device
    Intervention Name(s)
    navigated rTMS of motor cortex
    Other Intervention Name(s)
    Navigated, rTMS
    Intervention Description
    Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
    Intervention Type
    Device
    Intervention Name(s)
    navigated rTMS of somatosensory cortex 2
    Other Intervention Name(s)
    Navigated, rTMS
    Intervention Description
    Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks
    Intervention Type
    Device
    Intervention Name(s)
    SHAM rTMS with SHAM block
    Other Intervention Name(s)
    Navigated, rTMS, Placebo
    Intervention Description
    Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
    Primary Outcome Measure Information:
    Title
    Change in average pain compared to baseline
    Description
    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 Outcome Measure Information:
    Title
    Quality of life (EQ-5D)
    Description
    Questionnaire EQ-5D
    Time Frame
    One week after each arm of the study and 6 months after the last one
    Title
    Depression
    Description
    Questionnaire
    Time Frame
    One week after each arm of the study and 6 months after the last stimulation
    Title
    Change in average pain compared to baseline
    Description
    Phone call ( Numeric Rating Scale (NRS) in rest and movement )
    Time Frame
    2,3,4,5 and 6 months after the last stimulation
    Title
    Magnetoencephalography (MEG)
    Description
    Changes in the irritability of the motor cortex and somatosensory cortex
    Time Frame
    One week before and after each arms stimulations
    Title
    Number of patients with adverse effects
    Description
    Adverse effects are followed actively
    Time Frame
    From the start to the end of the study, on average 12 months per patient.
    Title
    Hands´ motor function and dexterity
    Description
    Nine hole peg, Pinch and Jamar
    Time Frame
    One week before and after each arm of the study
    Title
    Cold water test
    Description
    Conditioned pain modulation (CPM)
    Time Frame
    One week before and after each arm of the study
    Title
    Genetics
    Description
    Evaluation of genetical properties in terms of TMS related pain reduction
    Time Frame
    No time frame, just a blood sample

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eija Kalso, PhD, Prof.
    Organizational 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
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jyrki Mäkelä, MD, PhD
    Organizational Affiliation
    Head of laboratory, BioMag, Helsinki University Central Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Erika Kirveskari, MD, PhD
    Organizational Affiliation
    Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    That is not allowed according to the ethical committees decision.

    Learn more about this trial

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

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