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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Central Post Stroke Pain

Treatments: Device: navigated rTMS of somatosensory cortex 2; Device: SHAM rTMS with SHAM block; Device: navigated rTMS of motor cortex

Study type: Interventional

Funder types: Other

Identifiers

NCT02277912

TYH2013311

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

21 participants in 3 patient groups

Transcranial Magnetic Stimulation I

Experimental group

Description:

Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex

Treatment:

Device: navigated rTMS of motor cortex

Transcranial Magnetic Stimulation II

Experimental group

Description:

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

Treatment:

Device: navigated rTMS of somatosensory cortex 2

Sham Stimulation

Sham Comparator group

Description:

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

Treatment:

Device: SHAM rTMS with SHAM block