Spinal Networks of Balance Learning and Retention in Older Adults

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06517043
Status
Recruiting
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Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
65 Years - 95 Years
Healthy Volunteers
Accepted

Interventions

  • Balance Training — BEHAVIORAL
    Complex balance task involving static and dynamic weight shifting and coordinated stepping
  • Spinal Active tsDCS — DEVICE
    Active tsDCS over lumbar regions
  • Spinal Sham tsDCS — DEVICE
    Sham tsDCS over lumbar regions

Study Details

Age-related balance and walking issues increase fall risks, leading to injuries, higher healthcare costs, reduced quality of life, and increased morbidity/mortality rates. Preserving functional ability is a crucial public health priority, with the potential to reduce healthcare costs and enhance older adults' quality of life. Declines in balance and walking ability threaten independence. These declines are attributed to spinal network impairments and may be mitigated by targeted interventions aimed at addressing age-related spinal cord impairment to enhance functional outcomes. However, there is a lack of research into how the aging spinal cord affects balance/walking. In older adults, the spinal cord is less excitable, conducts signals more slowly, and is subject to neural noise. Intervening on age-related impairment of the spinal cord to improve balance/walking ability is a very promising but untapped area of research. A therapeutic approach that combines dynamic balance training with non-invasive electrical spinal stimulation may be effective in preserving functional abilities. This study tests whether electrical stimulation of the spinal lumbar regions is more beneficial than sham stimulation.

Key Dates

Start date
Jan 22, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active tsDCS treatment
    Participants will receive 30 minutes of continuous 2.5-mA tsDCS over the lumbar regions while engaging in a 30-minute complex balance task during each intervention session over a period of 2 weeks (every other day), totaling 5 intervention visits.
  • Sham Comparator: Sham tsDCS control
    Participants will receive 3 minutes of 2.5-mA tsDCS over the lumbar regions while engaging in a 30-minute complex balance task during each intervention session over a period of 2 weeks (every other day), totaling 5 intervention visits.

Primary Outcome Measure

Center of Pressure (COP) balance control [ Time Frame: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Malcom Randall VA Medical Center Brain Rehabilitation Research CenterGainesvilleFlorida32608
Brigette J Cox
[email protected]
352-376-1611

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By research site
Malcom Randall VA Medical Center Brain Rehabilitation Research Center· Gainesville, FL

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