Efficacy of tDCS on Pain Experience in People With Multiple Sclerosis: A Pilot Randomized Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- 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 with MS and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Pain in people with MS has the potential to become chronic, as a consequence of neuronal reorganization. Transcranial Direct Current Stimulation (tDCS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining tDCS with rehabilitation treatment may have effect in reducing pain in people with MS. This is a pilot randomized control trial to test the effects of tDCS in MS-related pain rehabilitation, its efficacy on pain (intensity, quality, interference with physical functioning), catastrophizing, emotional functioning and quality of life. Furthermore, we will explore the effects on pressure pain threshold and EEG recording. Correlations between sample characteristics and pain features will be investigated. Considering role of tDCS on neuropsychological functions, selective attention will be assessed.
Investigators
Sofia Straudi
Principal Investigator
University Hospital of Ferrara
Eligibility Criteria
Inclusion Criteria
- •chronic pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain, lasting more than 3 months with a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception;
- •lack of MS worsening in the three months just before the intervention period;
- •cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30.
Exclusion Criteria
- •worsening of MS-related conditions or changes in drug therapy or any other confounding factor during the study;
- •rehabilitation treatments or Botulinum toxin injections during the three months preceding the start of the study;
- •intracranial metal implants that can be stimulated, incorrectly positioned, or overheated by the electric current;
- •severe cardiopulmonary, renal, and hepatic diseases;
- •pregnancy.
Outcomes
Primary Outcomes
Numeric Rating Scale (NRS)
Time Frame: 4 weeks
Core outcome measure of pain intensity in chronic pain treatments' clinical trials
Secondary Outcomes
- Pressure Pain Threshold (PPT)(1 week, 4 weeks, 8 weeks)
- Short Form McGill Pain Questionnaire (SF-MPQ)(1 week, 4 weeks, 8 weeks)
- Patient Global Impression of Change (PGIC)(1 week, 4 weeks, 8 weeks)
- Pain Catastrophizing Scale (PCS)(1 week, 4 weeks, 8 weeks)
- Coping Strategies Questionnaire (CSQ)(1 week, 4 weeks, 8 weeks)
- Beck Depression Inventory II (BDI-II)(1 week, 4 weeks, 8 weeks)
- MS Quality of Life - 54 (MSQOL-54)(1 week, 4 weeks, 8 weeks)
- Go/No-go Task(1 week, 4 weeks, 8 weeks)
- Fatigue Severity Scale (FSS)(1 week, 4 weeks, 8 weeks)
- Brief Pain Inventory (BPI)(1 week, 4 weeks, 8 weeks)
- Electroencephalography (EEG) recordings(1 week, 4 weeks, 8 weeks)