RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06835283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. any contraindication for MRI
  2. 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. 3. current alcohol or substance use disorder determined by QuickSCID (nicotine allowed; mild cannabis and alcohol use is allowed)
  4. 4. neuropsychiatric symptoms (NPS) that are severe enough to preclude the intervention from being delivered safely and effectively, particularly agitation or aggression.

Contacts and Locations

Study Contact

Lane Witkowski Research Coordinator
CONTACT
206-419-1261
Lane.Witkowski@va.gov

Study Locations (Sites)

Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08
Study Completion Date2026-09

Study Record Updates

Study Start Date2025-08
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer's Disease
  • tDCS
  • iTBS
  • brain stimulation
  • mood swings

Additional Relevant MeSH Terms

  • Alzheimer&Amp;#39;s Disease-related Dementia
  • Alzheimer Disease
  • rTMS Stimulation