tDCS to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT03870048|
Recruitment Status : Completed
First Posted : March 11, 2019
Results First Posted : August 25, 2022
Last Update Posted : August 25, 2022
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The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on neuropathic pain and fatigue in people with MS. The investigators will conduct tDCS or sham on 5 consecutive days. They will evaluate pain and fatigue with specific questionnaires and measure fatigability with an isokinetic device.
The research question is whether tDCS can lessen neuropathic pain and increase fatigue resistance in people with MS. It is hypothesized, that less neuropathic pain and increased fatigue resistance after the tDCS sessions.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Device: transcranial direct current stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transcranial Direct Current Stimulation to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis|
|Actual Study Start Date :||April 15, 2019|
|Actual Primary Completion Date :||March 30, 2020|
|Actual Study Completion Date :||March 30, 2020|
Experimental: All Study Participants/tDCS or SHAM
tDCS Block: The participant will receive tDCS for 20 min at an intensity of 2 mA while seated comfortably and quietly in a room. The intensity will start at 0 mA and will be incrementally increased to 2mA over the initial 30 seconds. At the 19:30 minute time point, the current will gradually be reduced from 2 mA to 0 mA.
Sham block: Identical to the tDCS block, except the participants will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 for the remainder of the 20 minutes.
Device: transcranial direct current stimulation
A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.
- Neuropathic Pain Questionnaire (NPQ) Contains 12 Items. [ Time Frame: 2 Months ]The participant is asked to use items to rate their pain as it usually feels. They have to indicate a number which represents their pain on each scale. For example, if someone has no burning pain, the person would rate the first item "0". If the person has the worst burning pain imaginable, he/she would rate it "100". If neither of those fits his/her pain because it is in between, the participant has to choose a number which fits his/her pain.
- Fatigue Severity Scale (FSS) Contains Nine Statements That Attempt to Explore Severity of Fatigue Symptoms. [ Time Frame: 2 Months ]The FSS questionnaire The participant has to read each statement and circle a number from 1 to 7, depending on how appropriate they felt the statement applied to them over the preceding week. A low value indicates that the statement is not very appropriate whereas a high value indicates agreement (1 disagree, 7 agree).
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Medically diagnosed with Multiple Sclerosis
- 18-70 yrs. of age, moderate disability (Patient Determined Disease Steps (PDDS) core 2-6)
- Self-reported differences in function between legs
- Able to walk for 6 min
- Presenting with chronic, drug-resistant, neuropathic pain.
- Relapse within last 60 days
- High risk for cardiovascular disease (ACSM risk classification)
- Changes in disease modifying medications within last 45 days
- Concurrent neurological/neuromuscular disease
- Hospitalization within last 90 days
- Diagnosed depression
- Inability to understand/sign informed consent.
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): NCT03870048
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
Documents provided by Thorsten Rudroff, University of Iowa:
|Responsible Party:||Thorsten Rudroff, Principal Investigator, University of Iowa|
|Other Study ID Numbers:||
|First Posted:||March 11, 2019 Key Record Dates|
|Results First Posted:||August 25, 2022|
|Last Update Posted:||August 25, 2022|
|Last Verified:||August 2022|
|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:||Yes|
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