AgingEarly Phase 1NCT07208318
Restructuring the Alpha-Gamma Code in Aging Vision
A Early Phase 1 study testing High definition transcranial electrical current stimulation in people with Aging and Visual Perception, run by Boston University Charles River Campus at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Visual Perception, Noninvasive Brain Stimulation
- What is being tested?
- High definition transcranial electrical current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to 31 Aug 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+ years of age or older
- normal or corrected-to-normal visual acuity, color vision, and stereo vision
Who cannot join
- not pregnant,
- no metal implants in head,
- no implanted electronic devices,
- no history of neurological problems or head injury,
- no skin sensitivity,
- no claustrophobia,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
111 Cummington Mall, Boston University
Boston, Massachusetts, 02215
Robert Reinhart, PhD, 617-353-9481, rmgr@bu.edu
About this study
Official title: Rescuing Visual Perception in Aging Adults by Restructuring the Alpha-Gamma Neural Code
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.
Read the detailed description
The project probes a causal account of age-related perceptual decline by focusing on alpha-gamma phase-amplitude coupling (PAC) in early visual cortex and area MT. The central hypothesis is that aging alters both the magnitude and phase structure of alpha-gamma interactions, degrading visual performance; restoring a preferred configuration-gamma power nested at alpha troughs-should improve perception.
Multimodal methods combine structural/functional MRI, high-density EEG with source reconstruction, and individualized complex-waveform HD-tACS tuned to each participant's neuroanatomy and oscillatory frequencies. Three questions drive the work: (i) Do age-related deficits track changes in alpha-gamma PAC magnitude/phase? (ii) Can frequency-coupled HD-tACS enforce the preferred PAC configuration and enhance perception, especially in more impaired older adults? (iii) Is perception bidirectionally controllable by placing gamma at alpha troughs (facilitation) versus peaks (disruption)?
Two specific aims implement matched, five-day, within-subjects, double-blind, sham-controlled experiments with 120 participants each. Aim 1 targets early visual cortex to test whether contrast sensitivity deficits scale with age, spatial frequency, and noise, and whether personalized HD-tACS can optimize PAC to improve contrast perception. Aim 2 targets MT to test whether 3D shape-from-motion (parallax) judgments decline with age as a function of surface-point lifetime and simulated depth, and whether trough- versus peak-aligned stimulation can restructure PAC to enhance motion-based shape perception. Outcomes will establish mechanistic links between PAC and visual aging and evaluate a noninvasive, personalized intervention path relevant to age-related decline and ADRD.
- Conditions
- Aging, Visual Perception, Noninvasive Brain Stimulation
- Being tested
- High definition transcranial electrical current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition transcranial electrical current stimulationDevice
Low-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability.
| Study group | Role | What they receive |
|---|---|---|
| active stimulation | Experimental | Not described Receives: Device: High definition transcranial electrical current stimulation |
| sham stimulation | Sham comparator | Not described Receives: Device: High definition transcranial electrical current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
contrast sensitivity
Orientation identification task
Measured: 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
Measured: 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)
Measured: Baseline (pre-stimulation) and immediately post-stimulation, collected on each of the 5 study days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start2 Apr 2026
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Reinhart, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208318
- Sponsor's protocol ID
- 4230E_2
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescuing Visual Perception in Aging Adults by Restructuring the Alpha-Gamma Neural Code
- ClinicalTrials.gov ID
- NCT07208318
- Acronym / sponsor ID
- 4230E_2
- Conditions
- Aging, Visual Perception, Noninvasive Brain Stimulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The project probes a causal account of age-related perceptual decline by focusing on alpha-gamma phase-amplitude coupling (PAC) in early visual cortex and area MT. The central hypothesis is that aging alters both the magnitude and phase structure of alpha-gamma interactions, degrading visual performance; restoring a preferred configuration-gamma power nested at alpha troughs-should improve perception.
Multimodal methods combine structural/functional MRI, high-density EEG with source reconstruction, and individualized complex-waveform HD-tACS tuned to each participant's neuroanatomy and oscillatory frequencies. Three questions drive the work: (i) Do age-related deficits track changes in alpha-gamma PAC magnitude/phase? (ii) Can frequency-coupled HD-tACS enforce the preferred PAC configuration and enhance perception, especially in more impaired older adults? (iii) Is perception bidirectionally controllable by placing gamma at alpha troughs (facilitation) versus peaks (disruption)?
Two specific aims implement matched, five-day, within-subjects, double-blind, sham-controlled experiments with 120 participants each. Aim 1 targets early visual cortex to test whether contrast sensitivity deficits scale with age, spatial frequency, and noise, and whether personalized HD-tACS can optimize PAC to improve contrast perception. Aim 2 targets MT to test whether 3D shape-from-motion (parallax) judgments decline with age as a function of surface-point lifetime and simulated depth, and whether trough- versus peak-aligned stimulation can restructure PAC to enhance motion-based shape perception. Outcomes will establish mechanistic links between PAC and visual aging and evaluate a noninvasive, personalized intervention path relevant to age-related decline and ADRD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active stimulation | Experimental | Device: High definition transcranial electrical current stimulation |
| sham stimulation | Sham comparator | Device: High definition transcranial electrical current stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18+ years of age or older
- normal or corrected-to-normal visual acuity, color vision, and stereo vision
Key exclusion criteria (12 listed)
- not pregnant,
- no metal implants in head,
- no implanted electronic devices,
- no history of neurological problems or head injury,
- no skin sensitivity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High definition transcranial electrical current stimulationLow-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability. | Device | active stimulation, sham stimulation |
Primary outcome
contrast sensitivity
Time frame: Baseline (pre-stimulation) and immediately post-stimulation, collected on each of the 5 study days.
Orientation identification task
3D structural-from-motion
Time frame: Baseline (pre-stimulation) and immediately post-stimulation, collected on each of the 5 study days.
surface point lifetime (unlimited, 12 and 2 successive views) on 3D discrimination task
phase-amplitude coupling
Time frame: Baseline (pre-stimulation) and immediately post-stimulation, collected on each of the 5 study days.
alpha phase, gamma amplitude coupling (magnitude of coherency)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Aging
Not yet recruiting
Effects of Art-Based Group Reminiscence Therapy on Resilience and Joy of Living in Older Adults
Resilience, Psychological, Joy of Living
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing High definition transcranial electrical current stimulation in people with Aging and Visual Perception, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Reinhart, PhD ((617) 353-9481, rmgr@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contrast sensitivity (time frame: Baseline (pre-stimulation) and immediately post-stimulation, collected on each of the 5 study days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.