Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Cognitive Dysfunction Clinical Trial

Official title:

Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830942
• Other study ID #: IRB202300001
• Secondary ID: PRO00046897R01AG
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: David J Clark, ScD
• Phone: 352-376-1611
• Email: davidclark[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Efficacy of transcranial direct current stimulation (tDCS) combined with complex (cognitively engaging) walking exercise in older adults. The primary outcome measures are executive function (computer-based assessment battery) and complex walking function (speed on an obstacle negotiation task). This will be a two-site trial conducted at the University of Florida (lead site) and Brooks Rehabilitation Hospital, which is necessary to achieve enrollment targets and will allow us to develop a multi-site research infrastructure for a future Phase 3 multi-site trial. The study will enroll up to 120 older adult women and men, who exhibit mild to moderate decline of executive function. All experimental groups will receive the same complex walking intervention, which will focus on use of cognitively engaging tasks such as obstacle crossing, accurate foot placement, and walking on complaint surfaces. Each session will consist of 30 minutes of walking. For tDCS, the active treatment group will receive 20 minutes of 2mA tDCS over prefrontal regions F3/F4 ("treatment group"). The second group is a sham control group. tDCS will be delivered simultaneously with complex walking exercise for 18 sessions over a 6-week period. Assessments will be conducted at baseline, post intervention (within one week), and 12 weeks post-intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Frail Elderly
• Mobility Limitation

Intervention

Behavioral:
• Walking Exercise
aerobic walking exercise using complex (cognitively engaging) walking tasks

Device:
• Prefrontal Active tDCS
20 minutes of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session
• Prefrontal Sham tDCS
30 seconds of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Brooks Rehabilitation	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)