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NCT04391023 · ClinicalTrials.gov registry record · NA
Cerebellar tDCS and Balance Training in PwMS
A NA study, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT04391023 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 18 participants.
The verdict
NCT04391023, a NA study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Balance Training
- DEVICE Sham Transcranial Direct Current Stimulation (tDCS)
- DEVICE 2 mA Transcranial Direct Current Stimulation
- DEVICE 4 mA Transcranial Direct Current Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2023-07-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04391023
The ClinicalTrials.gov registry entry for NCT04391023 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Balance Training is the first listed.
NCT04391023 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04391023 about?
NCT04391023 is a clinical study titled "Cerebellar tDCS and Balance Training in PwMS". 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 balanc...
What is the current status of trial NCT04391023?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2022-09-26. Estimated completion is 2023-07-16.
What interventions are being tested in trial NCT04391023?
The interventions under investigation include: Balance Training (BEHAVIORAL), Sham Transcranial Direct Current Stimulation (tDCS) (DEVICE), 2 mA Transcranial Direct Current Stimulation (DEVICE), 4 mA Transcranial Direct Current Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04391023?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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