CONTROL Walking Study

NCT03790657 | Completed Phase 1 Results FDA Device

• 2 other identifiers: E3115-RI01RX003115
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Older adults often experience substantial deficits in walking ability, especially for walking tasks that are more complex such as obstacle crossing. This is due in part to changes in the brain that make performance of physical and cognitive tasks more difficult. Rehabilitation can help to improve walking ability, but effective rehabilitation is time consuming and expensive. New approaches are needed to improve the efficiency of rehabilitation so that gains in walking ability are widely attainable. A promising strategy is to focus on enhancing motor learning, which is defined as improved ability to perform a motor task due to practice or experience. The investigators will investigate the use of non-invasive brain stimulation to increase motor learning and retention of the newly learned walking skills. The investigators will also use neuroimaging to assess brain characteristics that explain how motor learning works. The knowledge gained from this study is expected to contribute to better understanding of mechanistic targets and intervention approaches to improve rehabilitation of walking.

Conditions

Aging

Keywords

aging; walking; brain; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Walking Speed Change From Baseline

  Change in the fastest safe walking speed over a complex walking course

  Measured at follow up visit (approximately three weeks after baseline)

Secondary Outcomes (2)

• Prefrontal Cortex Gray Matter Volume Change From Baseline

  Measured at follow up visit (approximately three weeks after baseline)

• Brain Resting State Network Segregation (Z-transformed Correlation Coefficient)

  Measured at follow up visit (approximately three weeks after baseline)

Study Arms (2)

Active tDCS

EXPERIMENTAL

20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task

Behavioral: practice of a complex walking task; Device: Active transcranial direct current stimulation (Active tDCS)

Sham tDCS

SHAM COMPARATOR

30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task

Behavioral: practice of a complex walking task; Device: Sham transcranial direct current stimulation (Sham tDCS)

Interventions

practice of a complex walking task BEHAVIORAL

walking over obstacles

Active tDCS; Sham tDCS

Active transcranial direct current stimulation (Active tDCS) DEVICE

mild electrical stimulation delivered to the frontal region of the brain

Active tDCS

Sham transcranial direct current stimulation (Sham tDCS) DEVICE

30 seconds of mild electrical stimulation delivered to the frontal region of the brain

Sham tDCS

Eligibility Criteria

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

You may qualify if:

• age 65 years or older
• preferred 10m walking speed \< 1.1 m/s
• self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores."
• Willingness to be randomized to either study group and to participate in all aspects of study assessment and intervention

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.)
• Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp)
• Contraindications to magnetic resonance imaging (e.g., metal in body, claustrophobia, etc).
• Use of medications affecting the central nervous system
• severe arthritis, such as awaiting joint replacement
• severe obesity (body mass index \> 35)
• current cardiovascular, lung or renal disease; 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
• uncontrolled hypertension at rest (systolic \> 180 mmHg and/or diastolic \> 100 mmHg)
• bone fracture or joint replacement in the previous six months
• current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation
• current enrollment in any clinical trial
• difficulty communicating with study personnel, and/or non-English speaking

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608-1135, United States

Location

Results Point of Contact

• Title: David Clark
• Organization: Malcom Randall VA Medical Center

david.clark1@va.gov

3523761611

Study Officials

• David J. Clark, DSc

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be told which dosage group they are assigned to. Outcomes Assessors will not be told which dosage group the participant was randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will randomized to one of two dosages of transcranial direct current stimulation (tDCS): Dosage A or Dosage B

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: December 31, 2018
• Study Start: August 1, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

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

Locations

US (1)