NCT05830942

Brief Summary

Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Apr 2024Apr 2027

First Submitted

Initial submission to the registry

April 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

April 11, 2023

Last Update Submit

May 5, 2025

Conditions

Cognitive DysfunctionMobility LimitationFrail Elderly

Outcome Measures

Primary Outcomes (2)

  • walking speed for obstacle task negotiation task

    change in walking speed from baseline to post intervention (or follow-up) timepoint

    baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)

  • score on test of executive function

    change in score from baseline to post intervention (or follow-up) timepoint

    baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)

Study Arms (2)

Walking Exercise plus active tDCS

ACTIVE COMPARATOR

The walking exercise will focus on use of complex walking tasks such as obstacle crossing, accurate foot placement, and walking on compliant surfaces. Each session will consist of 30 minutes of walking. Active tDCS will be delivered over prefrontal cortex.

Behavioral: Walking ExerciseDevice: Prefrontal Active tDCS

Walking Exercise plus sham tDCS

SHAM COMPARATOR

The walking exercise will focus on use of complex walking tasks such as obstacle crossing, accurate foot placement, and walking on compliant surfaces. Each session will consist of 30 minutes of walking. Sham tDCS will be delivered over prefrontal cortex.

Behavioral: Walking ExerciseDevice: Prefrontal Sham tDCS

Interventions

Walking ExerciseBEHAVIORAL

aerobic walking exercise using complex (cognitively engaging) walking tasks

Walking Exercise plus active tDCSWalking Exercise plus sham tDCS
Prefrontal Active tDCSDEVICE

20 minutes of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session

Walking Exercise plus active tDCS
Prefrontal Sham tDCSDEVICE

30 seconds of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session

Walking Exercise plus sham tDCS

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65+
  • Objective executive function decline, based on standardized cognitive assessments.
  • Subjective cognitive decline, based on the question: "During the past 12 months, have you experienced confusion or memory loss that is happening more often or getting worse?"
  • Ability to walking independently for 6 minutes (use of cane permitted)

You may not qualify if:

  • Major cognitive disorder that interferes with independence
  • Percentile score less than 10th percentile on standardized cognitive assessments
  • Medications that are thought to influence tDCS neuroplasticity.
  • Contraindications to tDCS or MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Brooks Rehabilitation

Jacksonville, Florida, 32653, United States

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionMobility Limitation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David J Clark, ScD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Clark, ScD

CONTACT

352-376-1611davidclark@ufl.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 26, 2023

Study Start

April 15, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)