Combined iTBS and tDCS brain stimulation for neuropsychiatric symptoms in Alzheimer's disease
Sequential Accelerated ITBS / Remote tDCS for Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease: A Pilot Study
This pilot tests a combined magnetic (iTBS) and electrical (tDCS) brain stimulation treatment to try to reduce mood swings, apathy, and agitation in people with mild-to-moderate Alzheimer's disease or related dementias.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06835283 on ClinicalTrials.gov |
What this trial studies
This pilot uses a sequential combination of intermittent theta burst stimulation (iTBS) delivered in clinic and daily transcranial direct current stimulation (tDCS) administered at home to target neuropsychiatric symptoms in Alzheimer's disease and related dementias. Participants attend nine visits over three months, including one week of in-clinic iTBS sessions followed by four weeks of caregiver-supported daily at-home tDCS, plus brain imaging and symptom questionnaires. The primary focus is feasibility and tolerability, with secondary collection of preliminary symptom change and caregiver-impact data to inform larger trials. Safety monitoring and exclusion of participants with MRI or stimulation contraindications are incorporated throughout the protocol.
Who should consider this trial
Good fit: Veterans aged 60–85 with a clinical diagnosis of mild-to-moderate Alzheimer's disease or related dementia (MMSE 15–23), clinically significant neuropsychiatric symptoms, a willing caregiver, and stable psychotropic medication regimens are eligible.
Not a fit: People with severe cognitive impairment outside the eligibility range, active substance use disorder, or contraindications to MRI or brain stimulation (for example, seizure disorder, certain implants, recent cortical stroke, or severe cardiovascular disease) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined, non-invasive stimulation could reduce behavioral and emotional symptoms and ease caregiver burden without adding medication side effects.
How similar studies have performed: Prior single-modality studies of rTMS/iTBS or tDCS have shown mixed but sometimes promising results for mood and cognitive symptoms, while combining iTBS plus tDCS in AD/ADRD is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- Michael E. DeBakey VA Medical Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Lane Witkowski Research Coordinator
- Email: Lane.Witkowski@va.gov
- Phone: 206-419-1261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.