Gamma-Music Based Intervention for Mild Alzheimer's Disease
Northeastern University · NCT05984524
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50–95 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 60
- US sites recruiting
- 1
- Study start
- July 1, 2022
- Record last updated
- October 6, 2023
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The study will test and refine a novel brain-stimulation tool using gamma-frequency lights coupled with self-selected music for a gamma-music-based intervention for participants with mild Alzheimer's Disease. Results will yield a gamma-stimulation protocol that reliably influences brain activity (Aim 1), is adaptive, motivating and rewarding to use (Aim 2), and will generate predictions as to who might benefit the most from gamma-MBI (Aim 3). By bridging the gap between neurostimulation and behavioral intervention by combining music therapy with gamma- band neurostimulation, the present project aims to find a sustainable intervention that delays the progression of AD.
Being studied: Gamma-Music Based Intervention
Conditions: Alzheimer Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Mild AD participants will be ages 55-90, amnestic (single or multiple domain) who perform below an education- adjusted cut-off score on the Logical Memory II subscale delayed paragraph recall of the Wechsler Memory Scale-Revised (WMS-R LM-IIa) (Wechsler 1987) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2), have a CDR global score of 0.5 (with a memory box score of 0.5 or 1), have an MMSE score of 20-24, and have preserved instrumental activities of daily living (ADL) as determined by the Alzheimer's Disease Cooperative Study ADL Prevention Instrument (ADCS ADL-PI). All participants will be medically stable. Participants will not have significant cerebrovascular disease determined by history of stroke, and will have a Modified Hachinski Ischemic score (Rosen et al. 1980) of ≤ 4. Participants will not have significant psychiatric disorders including a Geriatric Depression Scale (long form) (Yesavage et al. 1982) of ≤10, and will not have a history of substance or alcohol abuse. All participants must be on stable doses of any medications with psychotropic effects (including cholinesterase inhibitors, memantine, and antidepressants) for at least 3 months prior to randomization. Participants will be screened to be amyloid positive via plasma test. They must also have no contraindications to MRI scanning, and will have a study partner who is able to provide collateral information about the participant. A pure tone audiogram will be administered to ensure that participants have no more than mild levels of hearing loss (\<40dB). If a subject fails audiometric screening, they will be excluded from the study and provided with a list of audiologists. An Institutional Review Board (IRB) approved telephone screen will be used for demographic information, study inclusion/exclusion criteria and MRI contraindications. Participants will complete an MRI screening questionnaire before each MRI session.
Recruiting US locations
Northeastern University
Boston, MA 02115
Site contact: Eva Wu · 781-474-3141 · xi.wu@northeastern.edu
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