Efficacy of tDCS on Pain in Multiple Sclerosis

NCT03389217 | Unknown

• 1 other identifier: MS_tDCS_Pain
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Pain; Transcranial Direct Current Stimulation; tDCS

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  Core outcome measure of pain intensity in chronic pain treatments' clinical trials

  4 weeks

Secondary Outcomes (11)

• Short Form McGill Pain Questionnaire (SF-MPQ)

  1 week, 4 weeks, 8 weeks

• Brief Pain Inventory (BPI)

  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

Study Arms (2)

Real-tDCS + rehabilitation programme

EXPERIMENTAL

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.

Device: Real-tDCS + rehabilitation programme

Sham-tDCS + rehabilitation programme

ACTIVE COMPARATOR

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.

Device: Sham-tDCS + rehabilitation programme

Interventions

Real-tDCS + rehabilitation programme DEVICE

tDCS stimulation will be delivered using a constant current stimulator, with rechargeable batteries. The active electrode will be placed on the left dorsolateral prefrontal cortex (DLPFC) and the reference electrode will be placed over the controlateral supraorbital region. The direct current will be delivered through a pair of sponge electrodes with a surface of 35 cm2 (7 × 5), soaked in saline solution. This continuous stimulation will last 30 minutes, with an intensity of 1 mA. Rehabilitation programme will last for 30 minutes and includes specific exercises for prevention and management of pain. All the subjects enrolled will receive treatments for 4 weeks. During the first week the experimental group underwent tDCS daily (Monday-Friday) and rehabilitation programme 3 days per week. tDCS will be delivered before rehabilitation treatment. During the second, third and fourth week subjects will receive only rehabilitation treatment, 3 days per week.

Real-tDCS + rehabilitation programme

Sham-tDCS + rehabilitation programme DEVICE

The control group will receive the same protocol treatment but they underwent sham-tDCS during the first week of treatment. For sham condition tDCS, current was delivered for only 30 seconds and then the current was discontinued, but the tDCS apparatus was left in place for the same time as active tDCS (30 minutes)

Sham-tDCS + rehabilitation programme

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sofia Straudi, MD, PhD

  Ferrara Rehabilitation Hospital

  STUDY DIRECTOR

Central Study Contacts

Sofia Straudi, MD, PhD

CONTACT

+390532238720; s.straudi@ospfe.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: January 3, 2018
• Study Start: December 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)