Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT06517043

Conditions

Aging

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Balance Training

Spinal Active tsDCS

Spinal Sham tsDCS

Study Details

Brief summary:

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.

Conditions

Aging

Study ID

NCT06517043

Start date

Jan 22, 2025

Status verified date

Jun, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • age range: 65 to 95 years
  • no severe high blood pressure: Resting systolic < 180 mmHg and diastolic < 100 mmHg
  • no severe vision impairment: Visual acuity ≥ 20/70 as determined by Snellen eye chart
  • walking problem: Preferred walking speed slower than 1.0 m/s over 10 meters
  • balance problem: Berg Balance Scale score < 45
  • no cognitive impairment: Montreal Cognitive Assessment (MoCA) score ≥ 26 out of 30

Exclusion Criteria:

  • diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
  • severe arthritis, such as awaiting joint replacement
  • current cardiovascular, lung or renal disease; untreated diabetes; terminal illness
  • myocardial infarction or major heart surgery in the previous year
  • cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
  • current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
  • currently taking medications that affect the central nervous system, such as benzodiazepines, anti-cholinergic medication, and GABAergic medication, among others
  • uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
  • bone fracture or joint replacement in the previous six months
  • current enrollment in any other clinical trial
  • planning to relocate out of the area during the study period
  • non-English\* speaking, due to the likelihood of difficulties following instructions and communicating remotely
  • clinical judgment of the investigative team

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Balance Training

Complex balance task involving static and dynamic weight shifting and coordinated stepping

Spinal Active tsDCS

Active tsDCS over lumbar regions

Spinal Sham tsDCS

Sham tsDCS over lumbar regions

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) ]
  • Walking speed over obstacle course [ Time Frame: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention) ]
  • Spinal excitability via Soleus H-reflex testing [ Time Frame: Baseline and immediately following 30-minute intervention ]

Central Contacts and Locations

Central contacts

Jungyun Hwang, PhD

352-294-5458jungyunhwang@ufl.edu

Locations

Malcom Randall VA Medical Center Brain Rehabilitation Research Center

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Brigette J Cox

352-376-1611brigette.cox@phhp.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • aging
  • balance
  • walking
  • spinal cord
  • electrical stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-04.