Cerebellar tDCS and Balance Training in PwMS

NCT04391023 | Completed Results FDA Device

• 1 other identifier: 201912430
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Brain Stimulation; Balance Training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Time to Complete the Six Minute Walk Test (6MWT)

  24 hours, 2 weeks, and 4 weeks post-intervention

• Score on the Fatigue Severity Scale (FSS)

  24 hours, 2-weeks, and 4-weeks post-intervention

Study Arms (3)

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.

Device: Sham Transcranial Direct Current Stimulation (tDCS); Behavioral: Balance Training

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.

Behavioral: Balance Training; Device: 2 mA Transcranial Direct Current Stimulation

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.

Behavioral: Balance Training; Device: 4 mA Transcranial Direct Current Stimulation

Interventions

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.

Also known as: tDCS

Sham tDCS

Balance Training BEHAVIORAL

The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.

2 mA tDCS; 4 mA tDCS; Sham tDCS

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.

Also known as: tDCS

2 mA tDCS

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.

Also known as: tDCS

4 mA tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Alexandra Courtney Fietsam
• Organization: University of Iowa

alexandra-fietsam@uiowa.edu

N/A

Study Officials

• Alexandra Fietsam, M.S.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 18, 2020
• Study Start: September 26, 2022
• Primary Completion: July 16, 2023
• Study Completion: July 16, 2023
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Locations

US (1)