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Efficacy of tDCS on Pain in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03389217
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Real-tDCS + rehabilitation programme Device: Sham-tDCS + rehabilitation programme Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of tDCS on Pain Experience in People With Multiple Sclerosis: A Pilot Randomized Control Trial
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Real-tDCS + rehabilitation programme
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
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.

Active Comparator: Sham-tDCS + rehabilitation programme
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
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)




Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) [ Time Frame: 4 weeks ]
    Core outcome measure of pain intensity in chronic pain treatments' clinical trials


Secondary Outcome Measures :
  1. Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Assessment of sensory and affective dimensions of typical whole-body pain intensity.

  2. Brief Pain Inventory (BPI) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Assessment of the extent to which pain interferes with general activity, mood, walking, work, relationship with others, sleep, and enjoyment of life.

  3. Pain Catastrophizing Scale (PCS) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Assessment of a tendency to misinterpret or exaggerate apparently threatening situations that can lead to increased sensitivity to pain.

  4. Coping Strategies Questionnaire (CSQ) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Assessment of the frequency of coping strategies in response to pain.

  5. Beck Depression Inventory II (BDI-II) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Assessment of severity of common depressive symptoms.

  6. MS Quality of Life - 54 (MSQOL-54) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Multidimensional health-related quality of life measure that combines both generic and MS-specific items

  7. Fatigue Severity Scale (FSS) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Assessment of common features of fatigue in patients with multiple sclerosis

  8. Go/No-go Task [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Assessment of selective attention

  9. Patient Global Impression of Change (PGIC) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    Measure of participants' assessment of the clinical importance of their improvement or worsening over the course of a treatment

  10. Pressure Pain Threshold (PPT) [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.

  11. Electroencephalography (EEG) recordings [ Time Frame: 1 week, 4 weeks, 8 weeks ]
    EEG data will be recorded to test presence of particular brain activity in condition of pain chronicity and catastrophization.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389217


Contacts
Contact: Sofia Straudi, MD, PhD +390532238720 s.straudi@ospfe.it

Locations
Italy
Ferrara University Hospital Recruiting
Ferrara, Italy, 44124
Contact: Andrea Baroni, PT    +390532238720    brnndr3@unife.it   
Sub-Investigator: Sofia Straudi, MD, PhD         
Sub-Investigator: Sergio Buja, MD         
Sub-Investigator: Andrea Baroni, PT, MsC         
Sub-Investigator: Giulia Zani, PsyD         
Principal Investigator: Nino Basaglia, MD         
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
Study Director: Sofia Straudi, MD, PhD Ferrara Rehabilitation Hospital

Responsible Party: Sofia Straudi, MD, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03389217     History of Changes
Other Study ID Numbers: MS_tDCS_Pain
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sofia Straudi, MD, University Hospital of Ferrara:
Multiple Sclerosis
Pain
Transcranial Direct Current Stimulation
tDCS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases