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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Ferrara, Italy, 44124
        • Recruiting
        • Ferrara University Hospital
        • Contact:
        • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS)
Time Frame: 4 weeks
Core outcome measure of pain intensity in chronic pain treatments' clinical trials
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 week, 4 weeks, 8 weeks
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.
1 week, 4 weeks, 8 weeks
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.
1 week, 4 weeks, 8 weeks
Coping Strategies Questionnaire (CSQ)
Time Frame: 1 week, 4 weeks, 8 weeks
Assessment of the frequency of coping strategies in response to pain.
1 week, 4 weeks, 8 weeks
Beck Depression Inventory II (BDI-II)
Time Frame: 1 week, 4 weeks, 8 weeks
Assessment of severity of common depressive symptoms.
1 week, 4 weeks, 8 weeks
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
1 week, 4 weeks, 8 weeks
Fatigue Severity Scale (FSS)
Time Frame: 1 week, 4 weeks, 8 weeks
Assessment of common features of fatigue in patients with multiple sclerosis
1 week, 4 weeks, 8 weeks
Go/No-go Task
Time Frame: 1 week, 4 weeks, 8 weeks
Assessment of selective attention
1 week, 4 weeks, 8 weeks
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
1 week, 4 weeks, 8 weeks
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.
1 week, 4 weeks, 8 weeks
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.
1 week, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital of Ferrara

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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