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Transcranial Direct Current Stimulation and Walking in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03757819
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Thorsten Rudroff, University of Iowa

Brief Summary:

Weakness on one side of the body is a hallmark of Multiple Sclerosis (MS), which has been determined to be a significant cause of progressive worsening of walking abilities. Currently, there are no efficient rehabilitation strategies available to target strength asymmetries and walking impairments. Many of the current treatments, including pharmaceuticals, are only mildly effective and are often very expensive. Thus, the development of practical, inexpensive, and effective adjunct treatments is needed.

The study is to examine the efficacy of different tDCS protocols at improving walking in PwMS. Although the details of the studies slightly vary, the global aspects of the experimental procedures are identical with the exception that the tDCS stimulation parameter timing differs between the groups. The study will be double-blind, sham-controlled, randomized cross-over design.

Maximal voluntary contractions (MVCs) of the right and left knee extensors, knee flexors, hip flexors, and dorsiflexors will be performed to determine the more-affected leg.

The study compromises 2 groups of subjects which will attend the lab for three sessions. In the first session subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and a 6 minute walk test (6-MWT) for baseline performance. The second session will involve a 6 MWT performed in association with 2 conditions. Group 1: DURINGtDCS, DURINGSHAM. Group 2: BEFOREtDCS, BEFORESHAM. The conditions in each group will be in a randomized order. Intensity of tDCS will be 2mA for both groups. Group 1 will receive the conditions during the 6 MWT. tDCS for 6 min has been shown to be sufficient to induce cortical excitability. Group 2 will receive 13 min of tDCS or sham, which results in after effects lasting through the completion of the 6 MWT. tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg either before or during the 6 min walk test


Condition or disease Intervention/treatment Phase
Transcranial Direct Current Stimulation Device: tDCS Device: SHAM Not Applicable

Detailed Description:

Prospective participants, men and women with MS, will be recruited. To accomplish this study, each of the two groups of participants will need to complete 3 sessions at the INPL, each separated by 5-8 days. The duration of each session will be approximately one hour. The investigators expect data collection to last 6 months.

The study compromises 2 groups of subjects which will attend the lab for three sessions. In the first session subjects will be consented, complete the Patient Determined Disease Steps (PDDS) questionnaire, the Fatigue Severity Scale (FSS), and a 6MWT for baseline performance. The second session will involve a 6 MWT performed in association with 2 conditions. Group 1: DURING_tDCS, DURING_SHAM. Group 2: BEFORE_tDCS, BEFORE_SHAM. The conditions in each group will be in a randomized order. Intensity of tDCS will be 2mA for both groups. Group 1 will receive the conditions during the 6 MWT. tDCS for 6 min has been shown to be sufficient to induce cortical excitability. Group 2 will receive 13 min of tDCS or sham which results in after effects lasting through the completion of the 6MWT. tDCS will be applied to the motor cortex (M1)corresponding to the more-affected leg either before or during the 6 min walk test. Leg strength, 6 MWT, and tDCS: Maximal voluntary contractions (MVCs) of the right and left knee extensors, knee flexors, hip flexors, and dorsiflexors will be performed to determine the more-affected leg. When leg strength difference is less than 10%, the more affected side will be based on self-report. For the 6 MWT, participants will be asked to walk as far as they can in 6 minutes. The 6 MWT is well established in MS research and, in order to measure fatigability as a secondary outcome, the literature suggest using a 6MWT rather than a 2MWT.Participants will walk in a cordoned off hallway between two cones placed approximately 30 meters apart. The primary outcome measure will be the distance covered in the 6 MWT. Since the investigators hypothesize that tDCS will alter the utilization of their more-affected leg, standard gait metrics during the 6MWT including gait speed, cadence, stride length and time, step length and time will be assessed with inertial sensors (OPAL system) for tDCS and SHAM (secondary outcomes). Furthermore, the investigators will calculate the distance walked index (DWI, distance Min 1 - distance Min 6), which is an objective measure of fatigability. A tDCS device (ActivaDose II) 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. The following sessions will be performed in randomized order. Group 1 (During) - (A) The participant will receive tDCS or SHAM throughout the walking. In the tDCS trial the intensity will start at 0 mA and will be increased to 2mA over a 30 second period of time. At the 6:30 minute time point (immediately after walking) the current will gradually be reduced from 2 mA to 0 mA. (B) In the sham condition the participants will only receive the initial 30 seconds of stimulation, after which the current will be set to 0. Group 2 (Before) - (C) After a 30s ramp-up, tDCS will be delivered for 13 minutes at an intensity of 2 mA before the 6 min walk test. At the 13:00 minute time point the current will gradually be reduced from 2 mA to 0 mA. (D) Participants who undergo a sham condition will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 (D). In session 3, the condition not performed during session 2 will be performed. E.g., if a patient in Group 1 was randomly assigned DURING_SHAM for session 2, the patient will perform DURING_tDCS in session 3. All other testing conditions will be the same as session 2.

There will be no long-term follow up.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Can Transcranial Direct Stimulation Improve Walking in Multiple Sclerosis?
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Before Walking
To investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention.
Device: tDCS
Brain Stimulation

Device: SHAM
Placebo device

Experimental: During Walking
To investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention.
Device: tDCS
Brain Stimulation

Device: SHAM
Placebo device




Primary Outcome Measures :
  1. Distance walked [ Time Frame: Week 1 ]
    6 min walk test

  2. Distance walked [ Time Frame: Week 2 ]
    6 min walk test

  3. Distance walked [ Time Frame: Week 3 ]
    6 min walk test


Secondary Outcome Measures :
  1. Leg Extensor Strength [ Time Frame: Week 1 ]
    Isometric Strength of leg extensors

  2. Leg Flexor Strength [ Time Frame: Week 1 ]
    Isometric Strength of leg flexors



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,
  • moderate disability (Patient Determined Disease Steps (PDDS) core 2-6), -self-- reported differences in function between legs, able to walk for 6min. -

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): NCT03757819


Contacts
Contact: Thorsten Rudroff 7205323701 ext 7205323701 thorsten-rudroff@uiowa.edu

Locations
United States, Iowa
University of Iowa Not yet 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
Thorsten Rudroff
Investigators
Principal Investigator: Thorsten Rudroff University of Iowa

Responsible Party: Thorsten Rudroff, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03757819     History of Changes
Other Study ID Numbers: 201810705
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Thorsten Rudroff, University of Iowa:
Multiple Scerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases