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

NCT06835283 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-07

No results posted yet for this study

Summary

The goal of this pilot study is to test a combination of two non-invasive brain stimulation methods, called iTBS (intermittent theta burst stimulation) and tDCS (transcranial direct current stimulation), in people with Alzheimer's Disease (AD) and related dementias (ADRD). This study will also explore whether the combined treatment shows promise for reducing neuropsychiatric symptoms like mood swings, apathy, and agitation, and will evaluate the impact of the treatment on caregivers.

The main questions the study aims to answer are:

1. Is the combined brain stimulation treatment practical and well-tolerated?
2. Do preliminary results suggest that this treatment could help manage neuropsychiatric symptoms and support a larger study?

Participants will:

* Attend nine in-person visits over three months.
* Complete one week of in-clinic brain stimulation sessions (iTBS) followed by four weeks of daily at-home brain stimulation sessions (tDCS).
* Take part in brain scans, questionnaires, and brain activity tests before and after the treatment.

This pilot study is a first step to assess whether this combined treatment approach is practical and whether it has potential to improve symptoms, laying the groundwork for larger studies in the future.

Conditions

Interventions

DEVICE

Brain Stimulation

This intervention is distinct because it combines two non-invasive brain stimulation techniques, intermittent theta burst stimulation (iTBS) and transcranial direct current stimulation (tDCS), in a sequential manner. Unlike studies that evaluate these techniques individually, this study explores their combined and complementary effects, with iTBS priming the brain to enhance the subsequent impact of tDCS. The sequential design leverages different mechanisms of action: iTBS delivers magnetic pulses to targeted brain areas to modulate neural activity, while tDCS applies a low electrical current for sustained modulation. This approach specifically targets neuropsychiatric symptoms (e.g., mood swings, apathy, and agitation) in individuals with Alzheimer's Disease and related dementias (ADRD), a population often underserved by traditional interventions. The study also evaluates the feasibility of at-home tDCS administration, making it unique in combining clinical and caregiver-managed treat

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-07-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835283 on ClinicalTrials.gov