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tDCS to Lower Neuropathic Pain and Fatigue in People With 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. Read our disclaimer for details. Identifier: NCT03870048
Recruitment Status : Completed
First Posted : March 11, 2019
Results First Posted : August 25, 2022
Last Update Posted : August 25, 2022
Information provided by (Responsible Party):
Thorsten Rudroff, University of Iowa

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03870048

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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
  Study Documents (Full-Text)

Documents provided by Thorsten Rudroff, University of Iowa:
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Responsible Party: Thorsten Rudroff, Principal Investigator, University of Iowa Identifier: NCT03870048    
Other Study ID Numbers: 201812729
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neurologic Manifestations