Efficacy of rTMS on Pain Following Stroke.
- Conditions
- Stroke
- Interventions
- Device: Real-rTMS + Gloreha deviceDevice: Sham-rTMS + Gloreha device
- Registration Number
- NCT03354052
- Lead Sponsor
- University Hospital of Ferrara
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real-rTMS + Gloreha device Real-rTMS + Gloreha device - Sham-rTMS + Gloreha device Sham-rTMS + Gloreha device -
- Primary Outcome Measures
Name Time Method Numeric Rating Scale (NRS) Change measures (weeks: 0,2,6) Core outcome measure of pain intensity in pain treatments' clinical trials
- Secondary Outcome Measures
Name Time Method Short Form McGill Pain Questionnaire (SF-MPQ) Change measures (weeks: 0,2,6) Assessment of sensory and affective dimensions of typical whole-body pain intensity.
Beck Depression Inventory II (BDI-II) Change measures (weeks: 0,2,6) Assessment of severity of common depressive symptoms.
Neuropathic Pain Symptom Inventory (NPSI) Change measures (weeks: 0,2,6) A self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain.
Pressure Pain Threshold (PPT) Change measures (weeks: 0,2,6) PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.
Motor cortex excitability (single pulse TMS) Change measures (weeks: 0,2,6) Single pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I) Change measures (weeks: 0,2,6) Assessment of sensory function following brain injury.
Fugl-Meyer Assessment - Upper Extremity (FM-UE) Change measures (weeks: 0,2,6) Assessment of upper limb function.
Barthel Index (BI) Change measures (weeks: 0,2,6) Scale that measures disability or dependence in activities of daily living in stroke patients.
Electroencephalography (EEG) recordings Change measures (weeks: 0,2,6) EEG data will be recorded to test presence of particular brain activity in condition of pain.
Trial Locations
- Locations (1)
Ferrara University Hospital
🇮🇹Ferrara, Italy