Central Post Stroke PainNCT02277912
Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)
A study testing navigated rTMS of motor cortex and navigated rTMS of somatosensory cortex 2 in people with Central Post Stroke Pain, run by Helsinki University Central Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Post Stroke Pain
- What is being tested?
- navigated rTMS of motor cortex and navigated rTMS of somatosensory cortex 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Epilepsy
- Difficult aphasia
- Dementia
- Contraindication for TMS or MRI
- Alcohol and/or drug abuse
About this study
Official title: 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.
Read the 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.
- Conditions
- Central Post Stroke Pain
- Being tested
- navigated rTMS of motor cortex, navigated rTMS of somatosensory cortex 2, SHAM rTMS with SHAM block
- Keywords
- ICH, Stroke, Navigated, Placebo, TMS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated rTMS of motor cortexDevice
Also called Navigated, rTMS
Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
navigated rTMS of somatosensory cortex 2Device
Also called Navigated, rTMS
Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks
SHAM rTMS with SHAM blockDevice
Also called Navigated, rTMS, Placebo
Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation I | Experimental | Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex Receives: Device: navigated rTMS of motor cortex |
| Transcranial Magnetic Stimulation II | Experimental | Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex Receives: Device: navigated rTMS of somatosensory cortex 2 |
| Sham Stimulation | Sham comparator | Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex Receives: Device: SHAM rTMS with SHAM block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after each arm of the study
Secondary outcomes (8)
Quality of life (EQ-5D)
Questionnaire EQ-5D
Measured: One week after each arm of the study and 6 months after the last one
Depression
Questionnaire
Measured: One week after each arm of the study and 6 months after the last stimulation
Change in average pain compared to baseline
Phone call ( Numeric Rating Scale (NRS) in rest and movement )
Measured: 2,3,4,5 and 6 months after the last stimulation
Magnetoencephalography (MEG)
Changes in the irritability of the motor cortex and somatosensory cortex
Measured: One week before and after each arms stimulations
Number of patients with adverse effects
Adverse effects are followed actively
Measured: From the start to the end of the study, on average 12 months per patient.
Hands´ motor function and dexterity
Nine hole peg, Pinch and Jamar
Measured: One week before and after each arm of the study
Cold water test
Conditioned pain modulation (CPM)
Measured: One week before and after each arm of the study
Genetics
Evaluation of genetical properties in terms of TMS related pain reduction
Measured: No time frame, just a blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Post Stroke PainStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhani Ojala, Helsinki University Central Hospital
- Investigators
- Eija Kalso, PhD, Prof., 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 HospitalJyrki Mäkelä, MD, PhD, Study chair, Head of laboratory, BioMag, Helsinki University Central HospitalErika Kirveskari, MD, PhD, Study chair, Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277912
- Sponsor's protocol ID
- TYH2013311
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2014
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: That is not allowed according to the ethical committees decision.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain
- ClinicalTrials.gov ID
- NCT02277912
- Acronym / sponsor ID
- TYH2013311
- Conditions
- Central Post Stroke Pain
- Keywords
- ICH, Stroke, Navigated, Placebo, TMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation I | Experimental | Device: navigated rTMS of motor cortexIntervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex |
| Transcranial Magnetic Stimulation II | Experimental | Device: navigated rTMS of somatosensory cortex 2Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex |
| Sham Stimulation | Sham comparator | Device: SHAM rTMS with SHAM blockIntervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Epilepsy
- Difficult aphasia
- Dementia
- Contraindication for TMS or MRI
- Alcohol and/or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navigated rTMS of motor cortexAlso: Navigated, rTMSNavigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks. | Device | Transcranial Magnetic Stimulation I |
| navigated rTMS of somatosensory cortex 2Also: Navigated, rTMSNavigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks | Device | Transcranial Magnetic Stimulation II |
| SHAM rTMS with SHAM blockAlso: Navigated, rTMS, PlaceboRepetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks. | Device | Sham Stimulation |
Primary outcome
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.
8 secondary outcomes
Quality of life (EQ-5D)
Time frame: 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
Change in average pain compared to baseline
Time frame: 2,3,4,5 and 6 months after the last stimulation
Magnetoencephalography (MEG)
Time frame: 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.
Hands´ motor function and dexterity
Time frame: 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
Genetics
Time frame: No time frame, just a blood sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: No. That is not allowed according to the ethical committees decision.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eija Kalso, PhD, Prof. 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 study chair
Head of laboratory, BioMag, Helsinki University Central Hospital
Erika Kirveskari, MD, PhD study chair
Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing navigated rTMS of motor cortex and navigated rTMS of somatosensory cortex 2 in people with Central Post Stroke Pain, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average pain compared to baseline (time frame: 1 month after each arm of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.