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
About this trial
This is an interventional treatment trial for Central Post Stroke Pain focused on measuring ICH, Stroke, Navigated, Placebo, TMS
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
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
NCT ID
NCT02277912
First Posted
October 22, 2014
Last Updated
October 22, 2018
Sponsor
Helsinki University Central Hospital
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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