Aging Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 29, 2024 |
Est. primary completion date | November 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 360 degree Turn Duration | Turn duration as measured during a 360 degree turn task | 5 minutes, Measured two times approximately 3 weeks apart | |
Primary | 180 Degree Turn Duration | Turn duration as measured during a 2 minute walking task where participants walk back and fourth down a corridor. | 5 minutes, Measured two times approximately 3 weeks apart | |
Primary | 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 | |
Primary | Ratio of motor evoked potential amplitudes (no units) | Intracortical Facilitation (ICF) are paired-pulse TMS metrics of cortical inhibition and excitability, respectively. A short interval interstimulus (1-5 ms) leads to cortical inhibition reflective of GABAA-mediated network inhibition and longer interstimulus interval of 50-300 ms reflects GABAB-mediated local inhibition. The ratio of the peak-to-peak amplitude (in mV) of the second MEP to the first (or control) MEP will be calculated for each of these stimulation protocols. | 30 minutes, Measured at Baseline | |
Secondary | 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. | 5 minutes |
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