Cerebellar tDCS and Balance Training in PwMS

The Effects of 2 mA and 4 mA Cerebellar Transcranial Direct Current Stimulation and Balance Training to Reduce Fall Risk in People With Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Sham Transcranial Direct Current Stimulation (tDCS); Behavioral: Balance Training; Device: 2 mA Transcranial Direct Current Stimulation; Device: 4 mA Transcranial Direct Current Stimulation

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. medically diagnosed with relapsing-remitting multiple sclerosis
2. 18-70 years of age
3. moderate disability (score of 2-6 on the Patient Determined Disease Scale)
4. self-reported differences in function between legs, have fallen within the last year
5. able to walk for 6 mins, and not taking any psychoactive medication.

Exclusion Criteria:

1. relapse within the last 60 days
2. have changed disease modifying medications in the last 45 days
3. are currently pregnant
4. have a concurrent neurological or neuromuscular disease
5. have been hospitalized within the last 90 days
6. have any contraindications for the tDCS device (i.e., pacemakers or metal implants)
7. are unable to understand/sign the consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Device: 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.; Other Names: tDCS; Behavioral: Balance Training; The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
Experimental: 2 mA tDCS; 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.	Behavioral: Balance Training; The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.; Device: 2 mA Transcranial Direct Current Stimulation; 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.; Other Names: tDCS
Experimental: 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.	Behavioral: Balance Training; The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.; Device: 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.; Other Names: tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Alexandra Fietsam, M.S., University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): July 16, 2023
• Study Completion (Actual): July 16, 2023

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Brain Stimulation; Balance Training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 201912430

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes