Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease

NCT ID
NCT06835283
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Baylor College of Medicine
Conditions
Alzheimer Disease, Alzheimer&Amp;#39;s Disease-related Dementia, rTMS Stimulation

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: Sequential Accelerated ITBS / Remote tDCS for Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease: A Pilot Study

Enrollment: 20 participants (Estimated).

What is being studied

  • Device: Brain Stimulation
  • Intervention: Deep Brain Stimulation
  • Intervention: Electric Stimulation Therapy
  • Intervention: Surgical Procedures, Operative
  • Intervention: Therapeutics

Who may be eligible

Ages
65 Years to 85 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion criteria 1. veteran between the ages of 60 to 85 2. clinical diagnosis of mild to moderate Alzheimer's disease or related dementia 3. clinically significant neuropsychiatric symptoms (NPS) evidenced by a score ≥ 2 in at least one domain of the Neuropsychiatric Inventory Questionnaire 4. mild to moderate cognitive impairment demonstrated by a Mini-Mental State Examination (MMSE) score of 15-23 5. have a caregiver who is able and willing to escort the patient to/from clinic visits, answer questionnaires, and assist in the implementation of treatment sessions at home 6. if taking psychotropic medications, demonstrate stability for at least 4 weeks of treatment Exclusion Criteria: 1. any contraindication for MRI 2. any contraindication for iTBS/tDCS including but not limited to seizure disorder, severe cardiovascular disease, history of brain surgery, or stroke involving the cerebral cortex near area of stimulation 3. current alcohol or substance use disorder determined by QuickSCID (nicotine allowed; mild cannabis and alcohol use is allowed) 4. neuropsychiatric symptoms (NPS) that are severe enough to preclude the intervention from being delivered safely and effectively, particularly agitation or aggression. 6\) any unstable coexisting medical condition that in the opinion of the principal investigator(s) interferes with the treatment protocol or increase the likelihood of adverse events.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Texas, United States: 1

Sample of listed locations

  • Michael E. DeBakey VA Medical Center — Houston, Texas, 77030, United States — Site recruitment status not specified in the registry data

Study details

Start date
December 1, 2026
Primary completion date
July 1, 2027
Completion date
August 1, 2027
First posted
February 19, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06835283
Registry last updated
October 5, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT06835283 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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