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Many people with multiple sclerosis (PwMS) have decreased balance and postural control, gait deficits, and a high frequency of falls. High fall rates and mobility impairments pose a significant risk to the independence and quality of life of PwMS. Therefore, effective interventions to improve balance and postural control are urgently needed to decrease the frequency of falls in PwMS. Balance training has been demonstrated to significantly improve postural control and gait in PwMS. One possible treatment modality to amplify the effects of balance training is transcranial direct current stimulation (tDCS), a non-invasive means to increase cortical excitability and potentially prime the brain for task specific learning. The cerebellum plays a vital role in balance and posture and may be an important target structure for tDCS studies seeking to reduce fall risk. Studies have shown that anodal cerebellar tDCS is effective in improving balance control in older adults with high fall risk and patients with chronic stroke. However, the most effective tDCS intensity and the duration of the effects on balance control has not been established. Moreover, no study has combined cerebellar tDCS and balance training to reduce fall risk in PwMS. The purpose of this study is to investigate the effects of cerebellar transcranial direct current stimulation (tDCS) on fall risk in people with relapsing-remitting multiple sclerosis. We will conduct tDCS or SHAM followed by balance training on 4 consecutive days. We will evaluate fall risk with well-established functional tasks, such as the Berg Balance Scale, Timed Up and Go (TUG), the six minute walk test (6MWT), and static posturography.
Prospective participants, men and women with relapsing-remitting MS, will be recruited. To accomplish this study, 30 participants will be randomly assigned into 3 groups (2 mA tDCS, 4 mA tDCS, or SHAM). This study involves 4 daily visits at the Integrative Neurophysiology Lab at the same time of day for each subject and three follow-up visits. The duration of visit 1 will be approximately 2.5 hours and the duration of visits 2-4 will be approximately 1.5 hours. Visit 5, 6, and 7 will be approximately 24 hours, 1 week, and 3 weeks, respectively, after visit 4 and will last approximately 1.5 hours. During tDCS sessions, participants will undergo either Sham, 2 mA, and 4 mA tDCS for 20 minutes followed by balance training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham tDCS | Sham Comparator | The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA. |
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| 2 mA tDCS | Experimental | The participants in this group will receive tDCS at 2 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (2 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. |
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| 4 mA tDCS | Experimental | The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Transcranial Direct Current Stimulation (tDCS) | Device | tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum. |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Berg Balance Scale | The BBS is a valid and reliable assessment of balance during static (e.g., standing with eyes closed) and dynamic conditions (e.g., completing a 360-degree turn) conditions. BBS scores range from 0 to 56. Lower scores indicate increased impairment in balance. A cut-off score of 44 has been established as a criterion to identify PwMS with a high fall risk. | 24 hours, 2 weeks, and 4 weeks post-intervention |
| Time to Complete the Timed Up and Go Test (TUG) | The TUG measures the time it takes for the participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Two trials were completed and the reported score is the average time between the two trials. A higher number means it took the participant more time to complete the task (i.e., worse performance). | 24 hours, 2 weeks, and 4 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete the Six Minute Walk Test (6MWT) | Subjects performed the 6MWT in a cordoned-off hallway with two symbols on the ground, placed 30 meters apart. Subjects were instructed to walk as far as possible between the marks for 6 minutes, walking around each symbol like a cone. Higher scores indicate more distance walked (i.e., better performance). | 24 hours, 2 weeks, and 4 weeks post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Fietsam, M.S. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
No participants were assigned to the 2 mA tDCS group
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham tDCS | The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA. Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum. Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. |
| FG001 | 4 mA tDCS | The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. 4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham tDCS | The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA. Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum. Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Score on the Berg Balance Scale | The BBS is a valid and reliable assessment of balance during static (e.g., standing with eyes closed) and dynamic conditions (e.g., completing a 360-degree turn) conditions. BBS scores range from 0 to 56. Lower scores indicate increased impairment in balance. A cut-off score of 44 has been established as a criterion to identify PwMS with a high fall risk. | Posted | Mean | Standard Deviation | units on a scale | 24 hours, 2 weeks, and 4 weeks post-intervention |
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Adverse event data were collected through follow-up with each participating. This was from the familiarization session to the 4-week follow-up (~6-weeks total).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham tDCS | The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA. Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum. Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandra Courtney Fietsam | University of Iowa | N/A | alexandra-fietsam@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2023 | Oct 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Balance Training | Behavioral | The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. |
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| 2 mA Transcranial Direct Current Stimulation | Device | tDCS is a non-invasive brain stimulation technique in which very weak electrical current (2 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum. |
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| 4 mA Transcranial Direct Current Stimulation | Device | tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum. |
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| Score on the Fatigue Severity Scale (FSS) | The FSS consists of nine statements used to assess perceived fatigability. Subjects are asked to rate how much they felt a statement applied to them, on a 7-point scale (low value = does not apply, high value = high agreement with the statement). The questionnaire is scored by calculating the average response to the statements. Therefore, the scores will range from 1 to 7 (1 = low fatigue, 7 = high fatigue). A score ≥ 4 indicates a clinically significant level of fatigue. | 24 hours, 2-weeks, and 4-weeks post-intervention |
| BG001 | 4 mA tDCS | The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. 4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fatigue Severity Scale | The FSS consists of nine statements used to assess perceived fatigability. Subjects are asked to rate how much they felt a statement applied to them, on a 7-point scale (low value = does not apply, high value = high agreement with the statement). The questionnaire is scored by calculating the average response to the statements. Therefore, the scores will range from 1 to 7 (1 = low fatigue, 7 = high fatigue). A score ≥ 4 indicates a clinically significant level of fatigue. | Mean | Standard Deviation | units on a scale |
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| Functional Gait Assessment | The Functional Gait Assessment (FGA) assess postural stability and the ability of the subjects to perform motor tasks during walking. These tasks include demonstrating a change in gait speed, head turns during walking, and walking with a narrow base of support. The assessment consists of 10 tasks that are rated by an administrator on scale from 0 (severe impairment) to 3 (normal). Therefore, scores range from 0-30, with 30 being the highest score possible (normal ambulation). | Mean | Standard Deviation | units on a scale |
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| Berg Balance Scale | The Berg Balance Scale (BBS) is a valid and reliable assessment of balance during static (e.g., standing with eyes closed) and dynamic conditions (e.g., completing a 360-degree turn) conditions. BBS scores range from 0 to 56. Lower scores indicate increased impairment in balance. A cut-off score of 44 has been established as a criterion to identify people with MS with a high fall risk. | Mean | Standard Deviation | units on a scale |
|
| Six Minute Walk Test | Mean | Standard Deviation | meters |
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| Timed Up and Go | Mean | Standard Deviation | seconds |
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| OG001 | 4 mA tDCS | The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. 4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum. |
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| Primary | Time to Complete the Timed Up and Go Test (TUG) | The TUG measures the time it takes for the participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Two trials were completed and the reported score is the average time between the two trials. A higher number means it took the participant more time to complete the task (i.e., worse performance). | Posted | Mean | Standard Deviation | seconds | 24 hours, 2 weeks, and 4 weeks post-intervention |
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| Secondary | Time to Complete the Six Minute Walk Test (6MWT) | Subjects performed the 6MWT in a cordoned-off hallway with two symbols on the ground, placed 30 meters apart. Subjects were instructed to walk as far as possible between the marks for 6 minutes, walking around each symbol like a cone. Higher scores indicate more distance walked (i.e., better performance). | Posted | Mean | Standard Deviation | meters | 24 hours, 2 weeks, and 4 weeks post-intervention |
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| Secondary | Score on the Fatigue Severity Scale (FSS) | The FSS consists of nine statements used to assess perceived fatigability. Subjects are asked to rate how much they felt a statement applied to them, on a 7-point scale (low value = does not apply, high value = high agreement with the statement). The questionnaire is scored by calculating the average response to the statements. Therefore, the scores will range from 1 to 7 (1 = low fatigue, 7 = high fatigue). A score ≥ 4 indicates a clinically significant level of fatigue. | Posted | Mean | Standard Deviation | units on a scale | 24 hours, 2-weeks, and 4-weeks post-intervention |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 4 mA tDCS | The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. 4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| 4-weeks post-intervention |
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| 4-weeks post-intervention |
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| 4-weeks post-intervention |
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