Home-based self-administered transcranial direct current stimulation in older adults with knee osteoarthritis pain: An open-label study.
Hyochol Ahn, Setor Sorkpor, Hongyu Miao...
https://pubmed.ncbi.nlm.nih.gov/31153751Actively Recruiting
Phase Not Applicable
Age: 65Years - 85Years
All Genders
ID06835283
Sequential Accelerated ITBS / Remote tDCS for Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease: A Pilot Study
Led by Baylor College of Medicine · Updated on 2026-05-07
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring a new approach to manage behavioral and emotional symptoms in people with Alzheimer's Disease (AD) and related dementias (ADRD). This study evaluates a combined brain stimulation treatment using two non-invasive methods: intermittent theta burst stimulation (iTBS) and transcranial direct current stimulation (tDCS). The goal is to see if this combined treatment is practical, well-tolerated, and shows potential for reducing symptoms like mood swings, apathy, and agitation, while also assessing its impact on caregivers. Participants will first attend a week of in-clinic iTBS sessions using magnetic pulses targeting specific brain areas. This is followed by four weeks of daily at-home tDCS sessions, where participants self-administer low electrical currents using a portable device. Throughout the study, participants will undergo brain scans, questionnaires, and brain activity tests to monitor changes. The study includes nine in-person visits over three months, with close monitoring for safety and adherence. During the study, participants and their caregivers will be involved in various assessments including brain imaging and symptom questionnaires before and after treatment. Researchers will measure treatment feasibility and tolerability over five weeks, and also evaluate neuropsychiatric symptoms and caregiver burden. The study aims to gather preliminary data to support future larger trials and to understand how to best implement this combined brain stimulation approach for people with AD/ADRD.
CONDITIONS
Brief Title
Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease
Who Can Participate
Age: 65Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Veteran between 60 and 85 years old
- Clinical diagnosis of mild to moderate Alzheimer's Disease or related dementia
- Clinically significant neuropsychiatric symptoms with a score of 2 or higher in at least one domain of the Neuropsychiatric Inventory Questionnaire
- Mild to moderate cognitive impairment with Mini-Mental State Examination (MMSE) score between 15 and 23
- Have a caregiver able and willing to escort to clinic visits, answer questionnaires, and assist with at-home treatment
- Stable psychotropic medication use for at least 4 weeks if applicable
You will not qualify if you...
- Any contraindication for MRI
- Any contraindication for iTBS or tDCS, including seizure disorder, severe cardiovascular disease, history of brain surgery, or stroke near stimulation area
- Current alcohol or substance use disorder (nicotine allowed; mild cannabis and alcohol use allowed)
- Severe neuropsychiatric symptoms preventing safe or effective treatment, especially agitation or aggression
- Unstable medical conditions that interfere with treatment or increase risk of adverse events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 5 weeks
Participants receive a combination of two non-invasive brain stimulation treatments. During the first week, participants attend in-clinic iTBS sessions for five consecutive days applying magnetic pulses to targeted brain areas. This is followed by four weeks of daily, self-administered tDCS at home using a portable device delivering a low electrical current to modulate brain activity.
5 in-person visits during the first week and daily at-home treatment for 4 weeks
Follow-up
Duration - 1 week
Participants complete post-treatment assessments including brain scans, questionnaires, and evaluations of neuropsychiatric symptoms and caregiver burden to determine if improvements last after treatment ends.
1 post-treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
L
Lane Witkowski Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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