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

Central Post Stroke Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277912
• Other study ID #: TYH2013311
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2018
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Post Stroke Pain
• Stroke

Intervention

Device:
• navigated rTMS of motor cortex
Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
• navigated rTMS of somatosensory cortex 2
Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks
• SHAM rTMS with SHAM block
Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life (EQ-5D)	Questionnaire EQ-5D	One week after each arm of the study and 6 months after the last one
Secondary	Depression	Questionnaire	One week after each arm of the study and 6 months after the last stimulation
Secondary	Change in average pain compared to baseline	Phone call ( Numeric Rating Scale (NRS) in rest and movement )	2,3,4,5 and 6 months after the last stimulation
Secondary	Magnetoencephalography (MEG)	Changes in the irritability of the motor cortex and somatosensory cortex	One week before and after each arms stimulations
Secondary	Number of patients with adverse effects	Adverse effects are followed actively	From the start to the end of the study, on average 12 months per patient.
Secondary	Hands´ motor function and dexterity	Nine hole peg, Pinch and Jamar	One week before and after each arm of the study
Secondary	Cold water test	Conditioned pain modulation (CPM)	One week before and after each arm of the study
Secondary	Genetics	Evaluation of genetical properties in terms of TMS related pain reduction	No time frame, just a blood sample