Efficacy of tDCS on Pain Experience in People With Multiple Sclerosis: A Pilot Randomized Control Trial

Status unknownNot a drug-phase studyMS (type not specified)NCT03389217

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Real-tDCS + rehabilitation programme

Placebo

  • Sham-tDCS + rehabilitation programme

What it measured

Main measures

  • Numeric Rating Scale (NRS)

    4 weeks

    Pain

Other measures (11)

  • Short Form McGill Pain Questionnaire (SF-MPQ)

    1 week, 4 weeks, 8 weeks

    Pain
  • Brief Pain Inventory (BPI)

    1 week, 4 weeks, 8 weeks

    Walking and mobilityPainMood and sleep
  • Pain Catastrophizing Scale (PCS)

    1 week, 4 weeks, 8 weeks

    Pain
  • Coping Strategies Questionnaire (CSQ)

    1 week, 4 weeks, 8 weeks

    Pain
  • Beck Depression Inventory II (BDI-II)

    1 week, 4 weeks, 8 weeks

    Mood and sleep
  • MS Quality of Life - 54 (MSQOL-54)

    1 week, 4 weeks, 8 weeks

    Quality of life (reported by participants)
  • Fatigue Severity Scale (FSS)

    1 week, 4 weeks, 8 weeks

    Fatigue
  • Go/No-go Task

    1 week, 4 weeks, 8 weeks

    Thinking and memory
  • Patient Global Impression of Change (PGIC)

    1 week, 4 weeks, 8 weeks

  • Pressure Pain Threshold (PPT)

    1 week, 4 weeks, 8 weeks

    Pain

Who could take part

MS (type not specified) · 18 to 80

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Dec 2017

    2. Main results due

      Dec 2022

    3. Finished

      May 2023

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