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Completed

NCT Number: NCT02277912

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

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.

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Key information

Conditions

Central Post Stroke Pain Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

navigated rTMS of motor cortex

Device

Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.

Other names: Navigated, rTMS

navigated rTMS of somatosensory cortex 2

Device

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 rTMS with SHAM block

Device

Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.

Other names: Navigated, rTMS, Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2014
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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