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Clinical Trials/NCT04391023
NCT04391023
Completed
Not Applicable

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

University of Iowa1 site in 1 country18 target enrollmentSeptember 26, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Iowa
Enrollment
18
Locations
1
Primary Endpoint
Score on the Berg Balance Scale
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 26, 2022
End Date
July 16, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexandra Fietsmam

PhD Student

University of Iowa

Eligibility Criteria

Inclusion Criteria

  • medically diagnosed with relapsing-remitting multiple sclerosis
  • 18-70 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Score on the Berg Balance Scale

Time Frame: 24 hours, 2 weeks, and 4 weeks post-intervention

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.

Time to Complete the Timed Up and Go Test (TUG)

Time Frame: 24 hours, 2 weeks, and 4 weeks post-intervention

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).

Secondary Outcomes

  • 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 Sites (1)

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