Clinical trial NCT03389217: Efficacy of tDCS on Pain in Multiple Sclerosis
Official title: Efficacy of tDCS on Pain Experience in People With Multiple Sclerosis: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Pain
Transcranial Direct Current Stimulation
tDCS
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Brief Pain Inventory (BPI)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Coping Strategies Questionnaire (CSQ)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Beck Depression Inventory II (BDI-II)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: MS Quality of Life - 54 (MSQOL-54)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Go/No-go Task
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Pressure Pain Threshold (PPT)
timeFrame: 1 week, 4 weeks, 8 weeks
measure: Electroencephalography (EEG) recordings
timeFrame: 1 week, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara Rehabilitation Hospital
name: Sofia Straudi, MD, PhD
role: STUDY_DIRECTOR
References: