Transcranial Direct Current Stimulation and Walking in Multiple Sclerosis
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/31/2019 |
| Start Date: | January 28, 2018 |
| End Date: | December 2019 |
| Contact: | Thorsten Rudroff |
| Email: | thorsten-rudroff@uiowa.edu |
| Phone: | 7205323701 |
Can Transcranial Direct Stimulation Improve Walking in Multiple Sclerosis?
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
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
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.
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.
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.
We found this trial at
1
site
101 Jessup Hall
Iowa City, Iowa 52242
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Thorsten Rudroff, PhD
Phone: 720-532-3701
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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