Individual closed-loop brain stimulation for Alzheimer's-related memory loss
Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease
Researchers will test a personalized closed-loop 40 Hz transcranial alternating current stimulation (tACS) to see if it strengthens brain gamma rhythms and improves thinking in people aged 50–80 with amnestic MCI likely due to Alzheimer's.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Charlestown, Massachusetts) |
| Trial ID | NCT05904132 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled interventional protocol delivers individualized closed-loop 40 Hz tACS while monitoring EEG to patients with amnestic mild cognitive impairment likely due to Alzheimer's disease. Participants complete baseline and follow-up EEGs, questionnaires, and computerized cognitive tasks during each visit to measure neural entrainment and cognitive performance. The primary aims are to see whether closed-loop 40 Hz tACS can entrain natural gamma rhythms and improve cognitive performance, with exploratory analyses relating baseline neurodegenerative burden to treatment response. The intervention is noninvasive but excludes people with seizure history, scalp lesions, structural brain lesions, or significant uncontrolled medical conditions.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 50–80 with biomarker-supported amnestic MCI (CDR 0.5) likely due to Alzheimer's and no contraindications to tACS.
Not a fit: People with structural brain lesions, active serious medical illnesses, a history of seizures, long-term substance abuse, or more advanced dementia are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this approach could improve short-term cognitive performance and provide a basis for noninvasive therapies to slow memory decline.
How similar studies have performed: Preclinical work and small human studies of 40 Hz stimulation or sensory gamma entrainment have shown promising neural and biomarker effects, but consistent clinical cognitive benefits in Alzheimer's disease have not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported) * 50-80 years of age * English native speakers Exclusion Criteria: * Known presence of a structural brain lesion (e.g., tumor, cortical infarct) * Acute or decompensated active medical conditions, including cancer, cardiovascular disease, stroke, congestive heart failure * Active hematological, renal, pulmonary, endocrine or hepatic disorders * Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed * tACS contraindications (lesions in the scalp, history of seizures)
Where this trial is running
Charlestown, Massachusetts
- Massachusetts General Hospital — Charlestown, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Joan Camprodon, MD, PhD, MPH — MGH, Division of Neuropsychiatry and Neuromodulation
- Study coordinator: DNN Inbox
- Email: mghdnn@mgh.harvard.edu
- Phone: 6177265348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.