Clinical trial NCT06633952: Accelerating Cognitive Gains From Digital Inverventions With Noninvasive Brain Stimulation
Official title: Accelerating Cognitive Gains From Digital Meditation With Noninvasive Brain Stimulation: A Pilot Study in MCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
MCI
Keywords: healthy aging
cognitive decline
prevention
brain stimulation
attention
memory
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-09
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall goal of this project is to collect pilot feasibility and early efficacy data showing improvements in cognition and wellbeing in adults with mild cognitive impairment (MCI) through a combination treatment of non-invasive brain stimulation (transcranial alternating current stimulation (tACS)) and a one of two digital cognitive interventions.


Eligibility criteria: comfortably ambulatory healthy physical condition normal or corrected to normal visual auditory acuity fluency in spoken English Between 60-85 years old No neurological or psychiatric disorders No substance abuse Not taking anti-depressants Not taking anti-anxiety medication No history of seizures No color blindness No glaucoma No macular degeneration No amblyopia (lazy eye) No strabismus (cross eyed) Aneurysm clip(s) No Cardiac pacemaker No Implanted cardioverter defibrillator (ICD) No Electronic implant or device No Magnetically-activated implant or device No Neurostimulation system No Spinal cord stimulator No Internal electrodes or wires No Bone growth/bone fusion stimulator No Cochlear, otologic, or other ear implant No Insulin or other infusion pump No Implanted drug infusion device No type of prosthesis (eye, penile, etc.) No Heart valve prosthesis No Eyelid spring or wire No Artificial or prosthetic limb No Metallic stent, filter, or coil No Shunt (spinal or intraventricular) No Vascular access port and/or catheter No Radiation seeds or implants No Swan-Ganz or thermodilution catheter No Medication patch (Nicotine, Nitroglycerine) No metallic fragment or metallic foreign body in/on the body that can not be removed No Wire mesh implant No Tissue expander (e.g., breast) No Surgical staples, clips, or metallic sutures No Joint replacement (hip, knee, etc.) No Bone/joint pin, screw, nail, wire, plate, etc. No IUD, diaphragm, or pessary No Dentures or partial plates that can not be removed No Tattoo or permanent makeup No Body piercing jewelry No Claustrophobia

Primary outcomes:
measure: Mean change on the Continuous Performance Task (CPT) over time
timeFrame: baseline and immediate follow-up
Secondary outcomes:
measure: Mean change in Telomere length
timeFrame: baseline and immediate follow-up
measure: Mean change on a distracted attention task over time
timeFrame: baseline and immediate follow-up
measure: Mean Change in Frontal Theta Power over time
timeFrame: baseline and immediate follow-up
measure: Mean change in resting state networks over time
timeFrame: baseline and immediate follow-up
Other outcomes:
measure: Mean change on the Adaptive Cognitive Evaluation (ACE) over time
timeFrame: baseline and immediate follow-up
measure: Mean change in continuous recordings of sleep and stress metrics.
timeFrame: baseline and immediate follow-up
measure: Mean change in Change in Mnemonic Discrimination over time
timeFrame: baseline and immediate follow-up
measure: Mean change in Task-based Cortical Functional Connectivity
timeFrame: baseline and immediate follow-up
measure: Mean Change on Everyday Cognition Scale (ECog)
timeFrame: baseline and immediate follow-up
measure: Mean Change on SF-36 (overall health)
timeFrame: baseline and immediate follow-up
measure: Mean Change on Perceived Stress Scale
timeFrame: baseline and immediate follow-up
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: David Ziegler, PhD
role: PRINCIPAL_INVESTIGATOR
References: