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tDCS to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03870048
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
jkamholz
cdworkman
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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: tDCS effects on pain and fatigue
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.
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.

Placebo Comparator: Sham effects on pain and fatigue
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. Isokinetic Fatigue Test [ Time Frame: Through study completion, on average 1 year ]
    Participant's will perform 40 consecutive repetitions of isokinetic concentric/concentric flexion and extension of the knee on the more-affected leg at 120 degree/sec.

  2. Neuropathic Pain Questionnaire (NPQ) [ Time Frame: Through study completion, on average 1 year ]
    The Neuropathic Pain Questionnaire (NPQ) contains 12 items: 10 related to sensations or sensory responses and two related to affect. It has a sensitivity of 66% and a specificity of 74%. 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) [ Time Frame: Through study completion, on average 1 year ]
    Questionnaire: The FSS questionnaire contains nine statements that attempt to explore severity of fatigue symptoms. 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).


Other Outcome Measures:
  1. Duration of Relief [ Time Frame: One week following the post-intervention testing. ]

    If the participant indicates any reduction in pain following the previous day's tDCS session, they will be asked to estimate how long their pain was reduced following the session. One week following the post-intervention testing, participants will be contacted via telephone and asked the following questions:

    1. Was tDCS effective at reducing your pain?
    2. If so, how long did you notice a reduction in pain following your final tDCS session?
    3. Have you reduced your use of pain relieving medications since your last tDCS session?



Information from the National Library of Medicine

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03870048


Contacts
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Contact: Thorsten Rudroff 319467 ext 319467 thorsten-rudroff@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Thorsten Rudroff    720-532-3701 ext 7205323701    thorsten-rudroff@uiowa.edu   
Principal Investigator: Thorsten Rudroff, PhD         
Sponsors and Collaborators
University of Iowa
jkamholz
cdworkman

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Responsible Party: Thorsten Rudroff, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03870048     History of Changes
Other Study ID Numbers: 201812729
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: March 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Fatigue
Neuralgia
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations