Neural Underpinnings of Turning

Brain Networks of Turning Performance With Aging and Stroke

Older adults and stroke survivors often have difficulty performing complex walking tasks, due in part to changes in the brain. One task often overlooked is turning, which can lead to injury when performed poorly. The investigators will use non-invasive brain stimulation to assess brain activity and relate those observations to turning performance in older adults and stroke survivors.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: Experimental: Locomotor Learning

Detailed Description

This study is associated with an ongoing Clinical Trial (NCT03790657) called the CONTROL Walking Study, which combines locomotor learning and a form of non-invasive electrical brain stimulation call transcranial direct current stimulation (tDCS). The CONTROL Walking Study, randomly places participants into one of two experimental groups (transcranial direct current stimulation or sham stimulation). Following group placement participants complete a 2 week long walking and turning locomotor learning intervention while receiving a group dependent the form of tDCS or sham stimulation.

In leveraging the CONTROL Walking Study infrastructure to further examine the neural control of turning while walking, which is often impaired for older adults and people who have had a stroke. This study will assess neurophysiological brain function using transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation as well as assessing multiple forms of turning performance in older adults. Transcranial magnetic stimulation (TMS) will be used to assess cortical inhibitory neurophysiological function in motor networks of the brain. Importantly, recent work demonstrates significant associations between brain excitatory/inhibitory function and turning performance in older adults, although these results remain largely preliminary.

Therefore, the objective of this proposal is to further elucidate associations between neurophysiological function (measured with TMS) and 360 degree and 180 degree turning performance. The investigators will address the following specific aims:

Specific Aim 1 will test the hypothesis that greater cortical inhibition will be associated with shorter turn duration for 360 degree turns and 180 degree turns.

Specific Aim 2 will test the hypothesis that participants with greater baseline cortical inhibition will demonstrate larger 360 degree and 180 degree turning performance gains (i.e., shorter turn durations).

This new knowledge will provide additional information as to the neural mechanisms associated with turning performance in older adults. Moreover, these results could reveal mechanistic targets for future interventions to enhance turning performance learning and retention.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608-1135
      • North Florida/South Georgia Veterans Health System, Gainesville, FL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

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.)
• 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
• planning to relocate out of the area during the study period
• clinical judgment of investigative team regarding safety or non-compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Stimulation; Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.	Behavioral: Experimental: Locomotor Learning; Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation.
Experimental: Transcranial Direct Current Simulation; Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.	Behavioral: Experimental: Locomotor Learning; Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Cortical Silent Period (CSP) (ms)	Cortical Silent Period (CSP) is a single-pulse TMS measure of GABA-mediated cortical inhibition, in which stimulation is applied to the motor cortex while participants are activating a target muscle (here, the tibialis anterior muscle), resulting in a brief reduction in muscle activity. CSP is measured as the time during which the muscle activity is less than the pre-simulation muscle activity level until the return of voluntary muscle activity. CSP is measured in milliseconds (ms).	30 minutes, Measured at Baseline
360 Degree Turn Duration From Baseline	Change in 360 degree turn duration during a 360 degree turn test	Measured at follow up visit (approximately three weeks after baseline)
180 Degree Turn Duration From Baseline	Change in 180 degree turn duration as measured during a 2 minute walking task where participants walk back and forth down a corridor.	Measured at follow up visit (approximately three weeks after baseline)
Resting Motor Threshold (Percent of Machine Output)	Resting motor threshold (rMT) is obtained by single-pulse TMS and assesses voltage-gated sodium-channel-mediated cortical excitability. rMT is the minimum intensity (% machine output) of stimulation needed to repeatedly evoke a motor evoked potential (MEP) of at least 50 microvolts in over 50% of trials. It is reported as a percentage of total machine output.	20 minutes, Measured at Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Katz Independence Questionnaire	6-item participant reported questionnaire assessing level of independence [bathing, dressing, toileting, transferring, continence, feeding]. Total scores range: 0-6, the higher the score, the more independent.	Baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Clayton W Swanson, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Aging; Transcranial Magnetic Stimulation; Brain; Walking; Turning
• Other Study ID Numbers: N3954-M; 1IK1RX003954-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A limited dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
• IPD Sharing Time Frame: The Limited Dataset will be completed after the study is completed and primary/secondary data accepted for publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No