- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03389217
Efficacy of tDCS on Pain in Multiple Sclerosis
May 24, 2022 updated by: Sofia Straudi, University Hospital of Ferrara
Efficacy of tDCS on Pain Experience in People With Multiple Sclerosis: A Pilot Randomized Control Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sofia Straudi, MD, PhD
- Phone Number: +390532238720
- Email: s.straudi@ospfe.it
Study Locations
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-
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Ferrara, Italy, 44124
- Recruiting
- Ferrara University Hospital
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Contact:
- Andrea Baroni, PT
- Phone Number: +390532238720
- Email: brnndr3@unife.it
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Sub-Investigator:
- Sofia Straudi, MD, PhD
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Sub-Investigator:
- Sergio Buja, MD
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Sub-Investigator:
- Andrea Baroni, PT, MsC
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Sub-Investigator:
- Giulia Zani, PsyD
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Principal Investigator:
- Nino Basaglia, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
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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.
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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.
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Rating Scale (NRS)
Time Frame: 4 weeks
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Core outcome measure of pain intensity in chronic pain treatments' clinical trials
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form McGill Pain Questionnaire (SF-MPQ)
Time Frame: 1 week, 4 weeks, 8 weeks
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Assessment of sensory and affective dimensions of typical whole-body pain intensity.
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1 week, 4 weeks, 8 weeks
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Brief Pain Inventory (BPI)
Time Frame: 1 week, 4 weeks, 8 weeks
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Assessment of the extent to which pain interferes with general activity, mood, walking, work, relationship with others, sleep, and enjoyment of life.
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1 week, 4 weeks, 8 weeks
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Pain Catastrophizing Scale (PCS)
Time Frame: 1 week, 4 weeks, 8 weeks
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Assessment of a tendency to misinterpret or exaggerate apparently threatening situations that can lead to increased sensitivity to pain.
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1 week, 4 weeks, 8 weeks
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Coping Strategies Questionnaire (CSQ)
Time Frame: 1 week, 4 weeks, 8 weeks
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Assessment of the frequency of coping strategies in response to pain.
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1 week, 4 weeks, 8 weeks
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Beck Depression Inventory II (BDI-II)
Time Frame: 1 week, 4 weeks, 8 weeks
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Assessment of severity of common depressive symptoms.
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1 week, 4 weeks, 8 weeks
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MS Quality of Life - 54 (MSQOL-54)
Time Frame: 1 week, 4 weeks, 8 weeks
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Multidimensional health-related quality of life measure that combines both generic and MS-specific items
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1 week, 4 weeks, 8 weeks
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Fatigue Severity Scale (FSS)
Time Frame: 1 week, 4 weeks, 8 weeks
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Assessment of common features of fatigue in patients with multiple sclerosis
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1 week, 4 weeks, 8 weeks
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Go/No-go Task
Time Frame: 1 week, 4 weeks, 8 weeks
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Assessment of selective attention
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1 week, 4 weeks, 8 weeks
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Patient Global Impression of Change (PGIC)
Time Frame: 1 week, 4 weeks, 8 weeks
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Measure of participants' assessment of the clinical importance of their improvement or worsening over the course of a treatment
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1 week, 4 weeks, 8 weeks
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Pressure Pain Threshold (PPT)
Time Frame: 1 week, 4 weeks, 8 weeks
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PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.
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1 week, 4 weeks, 8 weeks
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Electroencephalography (EEG) recordings
Time Frame: 1 week, 4 weeks, 8 weeks
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EEG data will be recorded to test presence of particular brain activity in condition of pain chronicity and catastrophization.
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1 week, 4 weeks, 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sofia Straudi, MD, PhD, Ferrara Rehabilitation Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
November 16, 2017
First Submitted That Met QC Criteria
January 2, 2018
First Posted (Actual)
January 3, 2018
Study Record Updates
Last Update Posted (Actual)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS_tDCS_Pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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