Spinal Networks of Balance Learning and Retention in Older Adults

NCT06517043 | Recruiting DMC FDA Device

• 2 other identifiers: IRB202400382R21AG084944
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

aging; balance; walking; spinal cord; electrical stimulation

Outcome Measures

Primary Outcomes (3)

• Center of Pressure (COP) balance control

  Change in the center of pressure during static and dynamic postural control on a Dividat Senso pressure-sensitive plate will be assessed from baseline to post-intervention and follow-up.

  Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

• Walking speed over obstacle course

  Change in fastest walking speed over a 10-meter obstacle course on the GAITRite system will be assessed from baseline to post-intervention and follow-up.

  Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

• Spinal excitability via Soleus H-reflex testing

  Change in spinal excitability, measured via the soleus H-reflex testing using electromyography, will be assessed before and immediately following active or sham tsDCS (combined with balance training) during the 1st and 5th of the total five intervention sessions. The magnitude of change will be compared between these sessions.

  Baseline and immediately following 30-minute intervention

Secondary Outcomes (5)

• Score on standardized balance assessment (Berg Balance Scale)

  Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

• Score on standardized walking assessment (Functional Gait Assessment)

  Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

• Completion time on test of executive function (Trail Making Test)

  Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

• tsDCS treatment-related adverse events as assessed by a survey questionnaire.

  Baseline and following 30-minute intervention

• Prefrontal cortical activity using fNIRS

  Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

Study Arms (2)

Active tsDCS treatment

ACTIVE COMPARATOR

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.

Behavioral: Balance Training; Device: Spinal Active tsDCS

Sham tsDCS control

SHAM COMPARATOR

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.

Behavioral: Balance Training; Device: Spinal Sham tsDCS

Interventions

Balance Training BEHAVIORAL

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

Active tsDCS treatment; Sham tsDCS control

Spinal Active tsDCS DEVICE

Active tsDCS over lumbar regions

Active tsDCS treatment

Spinal Sham tsDCS DEVICE

Sham tsDCS over lumbar regions

Sham tsDCS control

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Malcom Randall VA Medical Center Brain Rehabilitation Research Center

Gainesville, Florida, 32608, United States

RECRUITING

Central Study Contacts

Jungyun Hwang, PhD

CONTACT

352-294-5458; jungyunhwang@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 24, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The Limited Dataset will be completed after the study is completed and primary/secondary data accepted for publication.

Locations

US (1)