Efficacy of rTMS on Pain Following Stroke: a Pilot Randomized Control Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University Hospital of Ferrara
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale (NRS)
- Last Updated
- 3 years ago
Overview
Brief Summary
Pain is a common symptom experienced by people following stroke and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Repetitive Transcranial Magnetic Stimulation (rTMS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining rTMS with rehabilitation treatment for primary motor cortex activation (using Gloreha® device) may have effect in reducing pain in stroke survivors. This is a pilot randomized control trial to test the effects of rTMS in stroke-related pain rehabilitation, its efficacy on pain, upper limb function, sensory function and autonomy in daily livings activities. Furthermore, we will explore the effects on pressure pain threshold, cortical excitability and EEG recording.
Investigators
Sofia Straudi
MD
University Hospital of Ferrara
Eligibility Criteria
Inclusion Criteria
- •diagnosis of first stroke verified by brain imaging \< 6 months
- •pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain and a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception
Exclusion Criteria
- •medical conditions likely to interfere with the ability to safely complete the study protocol
- •cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30
- •intracranial metal implants
- •history of seizures or epilepsy
- •severe cardiopulmonary, renal, and hepatic diseases
- •pregnancy
Outcomes
Primary Outcomes
Numeric Rating Scale (NRS)
Time Frame: Change measures (weeks: 0,2,6)
Core outcome measure of pain intensity in pain treatments' clinical trials
Secondary Outcomes
- Short Form McGill Pain Questionnaire (SF-MPQ)(Change measures (weeks: 0,2,6))
- Beck Depression Inventory II (BDI-II)(Change measures (weeks: 0,2,6))
- Neuropathic Pain Symptom Inventory (NPSI)(Change measures (weeks: 0,2,6))
- Pressure Pain Threshold (PPT)(Change measures (weeks: 0,2,6))
- Motor cortex excitability (single pulse TMS)(Change measures (weeks: 0,2,6))
- Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I)(Change measures (weeks: 0,2,6))
- Fugl-Meyer Assessment - Upper Extremity (FM-UE)(Change measures (weeks: 0,2,6))
- Barthel Index (BI)(Change measures (weeks: 0,2,6))
- Electroencephalography (EEG) recordings(Change measures (weeks: 0,2,6))