Efficacy of tDCS on Pain in Multiple Sclerosis

University Hospital of Ferrara

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Device: Sham-tDCS + rehabilitation programme; Device: Real-tDCS + rehabilitation programme

Study type: Interventional

Funder types: Other

Identifiers

NCT03389217

MS_tDCS_Pain

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Real-tDCS + rehabilitation programme

Experimental group

Description:

The real transcranial Direct Current Stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 30 minutes over the the left dorsolateral prefrontal cortex and rehabilitation programme for prevention and management of pain.

Treatment:

Device: Real-tDCS + rehabilitation programme

Sham-tDCS + rehabilitation programme

Active Comparator group

Description:

The sham transcranial Direct Current Stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 30 s over left dorsolateral prefrontal cortex and rehabilitation programme for prevention and management of pain.

Treatment:

Device: Sham-tDCS + rehabilitation programme