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

NCT02277912 | Completed

• 1 other identifier: TYH2013311
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Post Stroke Pain

Keywords

ICH; Stroke; Navigated; Placebo; TMS

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after each arm of the study

Secondary Outcomes (8)

• Quality of life (EQ-5D)

  One week after each arm of the study and 6 months after the last one

• Depression

  One week after each arm of the study and 6 months after the last stimulation

• Change in average pain compared to baseline

  2,3,4,5 and 6 months after the last stimulation

• Magnetoencephalography (MEG)

  One week before and after each arms stimulations

• Number of patients with adverse effects

  From the start to the end of the study, on average 12 months per patient.

Study Arms (3)

Transcranial Magnetic Stimulation I

EXPERIMENTAL

Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex

Device: navigated rTMS of motor cortex

Transcranial Magnetic Stimulation II

EXPERIMENTAL

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

Device: navigated rTMS of somatosensory cortex 2

Sham Stimulation

SHAM COMPARATOR

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

Device: SHAM rTMS with SHAM block

Interventions

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.

Also known as: Navigated, rTMS

Transcranial Magnetic Stimulation I

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

Also known as: Navigated, rTMS

Transcranial Magnetic Stimulation II

SHAM rTMS with SHAM block DEVICE

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

Also known as: Navigated, rTMS, Placebo

Sham Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Epilepsy
• Difficult aphasia
• Dementia
• Contraindication for TMS or MRI
• Alcohol and/or drug abuse

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 29, 2014
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share