Transcranial Pulse Stimulation of the Brain in Older Adults With and Without Mild Dementia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will investigate transcranial pulse stimulation (TPS) as a method of enhancing cognitive and neural function. The study team will apply this low intensity, magnetically pulse technology to key brain regions in a randomized, sham-controlled trial (RCT). The study will determine the magnitude of changes in cognitive function and brain function and structure between a pre- and post-stimulation among 10 typically-aging older adults and 10 patients with mild dementia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 84
Healthy Volunteers: f
View:

• Men and women

• Age: 65 to 84 years

• English speaking

• Physically mobile with no history of balance difficulties or major falls

• For the typically-aging older adult group, phone screening performance on the TICS must be greater than or equal to 33 points, and cognitive performance of 26 points or greater on the MoCA and a Sum of Boxes score of 0 on the Clinical Dementia Rating scale administered to the participant's informant at the initial visit

• For the Mild dementia group, phone screening performance on the TICS must be between 21 and 32 points, and subsequent cognitive performance of on the MoCA must be \<23 with a CDR Sum of Boxes score between 4.5 and 9.0 as administered to the participants known informant at the initial visit.

Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Joseph M Gullett, Ph.D.
gullettj@phhp.ufl.edu
352-294-8631
Time Frame
Start Date: 2024-02-16
Estimated Completion Date: 2026-07-07
Participants
Target number of participants: 20
Treatments
Active_comparator: Active brain stimulation
These participants will receive focused TPS (pulsed stimulation) of the specified default mode network regions as specified in the detailed study description.
Sham_comparator: Sham brain stimulation
These participants will also receive focused TPS (pulsed stimulation) of the specified default mode network regions as specified in the detailed study description, though the device will be set to Sham in a blinded fashion by the biostatistician by placing an air pouch in the device hand piece.
Related Therapeutic Areas
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov