Central Post Stroke Pain
Conditions
Keywords
ICH, Stroke, Navigated, Placebo, TMS
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.
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.
Interventions
DEVICEnavigated rTMS of motor cortex
Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
DEVICEnavigated 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
DEVICESHAM rTMS with SHAM block
Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in average pain compared to baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Depression | One week after each arm of the study and 6 months after the last stimulation | Questionnaire |
| Change in average pain compared to baseline | 2,3,4,5 and 6 months after the last stimulation | Phone call ( Numeric Rating Scale (NRS) in rest and movement ) |
| Magnetoencephalography (MEG) | One week before and after each arms stimulations | Changes in the irritability of the motor cortex and somatosensory cortex |
| Quality of life (EQ-5D) | One week after each arm of the study and 6 months after the last one | Questionnaire EQ-5D |
| Hands´ motor function and dexterity | One week before and after each arm of the study | Nine hole peg, Pinch and Jamar |
| Cold water test | One week before and after each arm of the study | Conditioned pain modulation (CPM) |
| Genetics | No time frame, just a blood sample | Evaluation of genetical properties in terms of TMS related pain reduction |
| Number of patients with adverse effects | From the start to the end of the study, on average 12 months per patient. | Adverse effects are followed actively |
Outcome results
None listed