Cerebellar tDCS and Balance Training in PwMS

NCT ID: NCT04391023

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2023-07-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

Balance Training

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Balance Training

Intervention Type: BEHAVIORAL

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

2 mA Transcranial Direct Current Stimulation

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Balance Training

Intervention Type: BEHAVIORAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Balance Training

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

tDCS; tDCS; tDCS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Fietsmam

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra Fietsam, M.S.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201912430

Identifier Type: -

Identifier Source: org_study_id