Restructuring the Alpha-Gamma Code in Aging Vision

NCT07208318 | Not Yet Recruiting Early Phase 1 FDA Device

• 1 other identifier: 4230E_2
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tests whether age-related visual deficits arise from disrupted alpha-gamma coupling in visual cortex (V1) and MT. Uses fMRI, source-resolved HD-EEG, and personalized complex-waveform HD-tACS to (1) quantify aging effects on phase-amplitude coupling, (2) drive PAC into a preferred "gamma-at-alpha-troughs" state, and (3) bidirectionally change perception by aligning gamma to alpha troughs vs peaks. Two five-day, double-blind, sham-controlled studies (n=120 each) target contrast sensitivity (V1) and 3D shape-from-motion (MT), aiming for mechanistic insight and remediation in older adults with implications for ADRD.

Conditions

Aging; Visual Perception; Noninvasive Brain Stimulation

Outcome Measures

Primary Outcomes (3)

• contrast sensitivity

  Orientation identification task

  Baseline (pre-stimulation) and immediately post-stimulation, collected on each of the 5 study days.

• 3D structural-from-motion

  surface point lifetime (unlimited, 12 and 2 successive views) on 3D discrimination task

  Baseline (pre-stimulation) and immediately post-stimulation, collected on each of the 5 study days.

• phase-amplitude coupling

  alpha phase, gamma amplitude coupling (magnitude of coherency)

  Baseline (pre-stimulation) and immediately post-stimulation, collected on each of the 5 study days.

Study Arms (2)

active stimulation

EXPERIMENTAL

Device: High definition transcranial electrical current stimulation

sham stimulation

SHAM COMPARATOR

Device: High definition transcranial electrical current stimulation

Interventions

High definition transcranial electrical current stimulation DEVICE

Low-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability.

active stimulation; sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age or older
• normal or corrected-to-normal visual acuity, color vision, and stereo vision

You may not qualify if:

• not pregnant,
• no metal implants in head,
• no implanted electronic devices,
• no history of neurological problems or head injury,
• no skin sensitivity,
• no claustrophobia,
• no dementia (normal Mini Mental State Examination between 24-30; Montreal Cognitive Assessment \> 25)
• no depression (normal Beck Depression Inventory II \<13; Geriatric Depression Scale \< 10)
• no ophthalmological diseases (e.g., strabismus, glaucoma, cataract, macular degeneration)
• no history of psychosis
• no cognitive deficits (MMSE score\>24; MoCA\>25)
• cannot be taking any psychoactive medication.

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Central Study Contacts

Robert Reinhart, PhD

CONTACT

(617) 353-9481; rmgr@bu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 6, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share