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Efficacy of tDCS on Pain in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Real-tDCS + rehabilitation programme
Sham-tDCS + rehabilitation programme
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Pain, Transcranial Direct Current Stimulation, tDCS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ferrara University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Real-tDCS + rehabilitation programme

Sham-tDCS + rehabilitation programme

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS)
Core outcome measure of pain intensity in chronic pain treatments' clinical trials

Secondary Outcome Measures

Short Form McGill Pain Questionnaire (SF-MPQ)
Assessment of sensory and affective dimensions of typical whole-body pain intensity.
Brief Pain Inventory (BPI)
Assessment of the extent to which pain interferes with general activity, mood, walking, work, relationship with others, sleep, and enjoyment of life.
Pain Catastrophizing Scale (PCS)
Assessment of a tendency to misinterpret or exaggerate apparently threatening situations that can lead to increased sensitivity to pain.
Coping Strategies Questionnaire (CSQ)
Assessment of the frequency of coping strategies in response to pain.
Beck Depression Inventory II (BDI-II)
Assessment of severity of common depressive symptoms.
MS Quality of Life - 54 (MSQOL-54)
Multidimensional health-related quality of life measure that combines both generic and MS-specific items
Fatigue Severity Scale (FSS)
Assessment of common features of fatigue in patients with multiple sclerosis
Go/No-go Task
Assessment of selective attention
Patient Global Impression of Change (PGIC)
Measure of participants' assessment of the clinical importance of their improvement or worsening over the course of a treatment
Pressure Pain Threshold (PPT)
PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.
Electroencephalography (EEG) recordings
EEG data will be recorded to test presence of particular brain activity in condition of pain chronicity and catastrophization.

Full Information

First Posted
November 16, 2017
Last Updated
May 24, 2022
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT03389217
Brief Title
Efficacy of tDCS on Pain in Multiple Sclerosis
Official Title
Efficacy of tDCS on Pain Experience in People With Multiple Sclerosis: A Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Pain, Transcranial Direct Current Stimulation, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real-tDCS + rehabilitation programme
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-tDCS + rehabilitation programme
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Real-tDCS + rehabilitation programme
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham-tDCS + rehabilitation programme
Intervention Description
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 Measure Information:
Title
Numeric Rating Scale (NRS)
Description
Core outcome measure of pain intensity in chronic pain treatments' clinical trials
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Short Form McGill Pain Questionnaire (SF-MPQ)
Description
Assessment of sensory and affective dimensions of typical whole-body pain intensity.
Time Frame
1 week, 4 weeks, 8 weeks
Title
Brief Pain Inventory (BPI)
Description
Assessment of the extent to which pain interferes with general activity, mood, walking, work, relationship with others, sleep, and enjoyment of life.
Time Frame
1 week, 4 weeks, 8 weeks
Title
Pain Catastrophizing Scale (PCS)
Description
Assessment of a tendency to misinterpret or exaggerate apparently threatening situations that can lead to increased sensitivity to pain.
Time Frame
1 week, 4 weeks, 8 weeks
Title
Coping Strategies Questionnaire (CSQ)
Description
Assessment of the frequency of coping strategies in response to pain.
Time Frame
1 week, 4 weeks, 8 weeks
Title
Beck Depression Inventory II (BDI-II)
Description
Assessment of severity of common depressive symptoms.
Time Frame
1 week, 4 weeks, 8 weeks
Title
MS Quality of Life - 54 (MSQOL-54)
Description
Multidimensional health-related quality of life measure that combines both generic and MS-specific items
Time Frame
1 week, 4 weeks, 8 weeks
Title
Fatigue Severity Scale (FSS)
Description
Assessment of common features of fatigue in patients with multiple sclerosis
Time Frame
1 week, 4 weeks, 8 weeks
Title
Go/No-go Task
Description
Assessment of selective attention
Time Frame
1 week, 4 weeks, 8 weeks
Title
Patient Global Impression of Change (PGIC)
Description
Measure of participants' assessment of the clinical importance of their improvement or worsening over the course of a treatment
Time Frame
1 week, 4 weeks, 8 weeks
Title
Pressure Pain Threshold (PPT)
Description
PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.
Time Frame
1 week, 4 weeks, 8 weeks
Title
Electroencephalography (EEG) recordings
Description
EEG data will be recorded to test presence of particular brain activity in condition of pain chronicity and catastrophization.
Time Frame
1 week, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Straudi, MD, PhD
Phone
+390532238720
Email
s.straudi@ospfe.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
Organizational Affiliation
Ferrara Rehabilitation Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ferrara University Hospital
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Baroni, PT
Phone
+390532238720
Email
brnndr3@unife.it
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sergio Buja, MD
First Name & Middle Initial & Last Name & Degree
Andrea Baroni, PT, MsC
First Name & Middle Initial & Last Name & Degree
Giulia Zani, PsyD
First Name & Middle Initial & Last Name & Degree
Nino Basaglia, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of tDCS on Pain in Multiple Sclerosis

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