Efficacy of tDCS on Pain in Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03389217|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Device: Real-tDCS + rehabilitation programme Device: Sham-tDCS + rehabilitation programme|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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)
- Numeric Rating Scale (NRS) [ Time Frame: 4 weeks ]Core outcome measure of pain intensity in chronic pain treatments' clinical trials
- 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.
- 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.
- 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.
- Coping Strategies Questionnaire (CSQ) [ Time Frame: 1 week, 4 weeks, 8 weeks ]Assessment of the frequency of coping strategies in response to pain.
- Beck Depression Inventory II (BDI-II) [ Time Frame: 1 week, 4 weeks, 8 weeks ]Assessment of severity of common depressive symptoms.
- 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
- Fatigue Severity Scale (FSS) [ Time Frame: 1 week, 4 weeks, 8 weeks ]Assessment of common features of fatigue in patients with multiple sclerosis
- Go/No-go Task [ Time Frame: 1 week, 4 weeks, 8 weeks ]Assessment of selective attention
- 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
- 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.
- 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.
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
|Contact: Sofia Straudi, MD, PhDfirstname.lastname@example.org|
|Ferrara University Hospital||Recruiting|
|Ferrara, Italy, 44124|
|Contact: Andrea Baroni, PT +390532238720 email@example.com|
|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|
|Study Director:||Sofia Straudi, MD, PhD||Ferrara Rehabilitation Hospital|