Brain Stimulation for Alzheimer's Disease

Overseen By Lane Witkowski Research Coordinator

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Seizure disorder, Severe cardiovascular disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to assist individuals with Alzheimer's by using two non-invasive brain stimulation techniques, known as iTBS and tDCS Combination Treatment. The goal is to determine if these methods can ease symptoms like mood swings and agitation and assess their ease of use at home. Researchers will monitor participants through brain scans and questionnaires to track any changes. Veterans with mild to moderate Alzheimer's who experience noticeable mood or behavior changes may find this study suitable. The study also involves a caregiver to assist with treatment. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in Alzheimer's treatment.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are on psychotropic medications, they must be stable for at least 4 weeks before starting the trial.

What prior data suggests that this combination of brain stimulation methods is safe for people with Alzheimer's Disease?

Research has shown that both iTBS (intermittent theta burst stimulation) and tDCS (transcranial direct current stimulation) are generally safe and well-tolerated. Studies using similar brain stimulation methods have found no major safety issues.

For iTBS, some studies noted improvements in memory and verbal skills, with no serious side effects reported. Similarly, tDCS has been tested in people with Alzheimer's, and research suggests it might help improve thinking abilities without significant negative effects.

Overall, current research considers these non-invasive brain stimulation techniques safe for people with Alzheimer's and related dementias. Participants might feel mild discomfort during treatment, but serious risks are not commonly reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of iTBS and tDCS for Alzheimer's disease because it offers a non-invasive approach to brain stimulation that could directly target and modulate brain activity. Unlike traditional treatments that primarily rely on medications to manage symptoms, this method uses magnetic pulses and electrical currents to influence specific brain areas associated with neuropsychiatric symptoms. The potential for patients to self-administer tDCS at home is another exciting aspect, as it could make ongoing treatment more accessible and convenient. This approach might lead to improvements in symptom severity in a relatively short time frame compared to current standard treatments.

What evidence suggests that this brain stimulation treatment might be effective for Alzheimer's Disease?

Research has shown that both iTBS and tDCS can improve thinking and memory in individuals with memory problems. Studies have found that iTBS boosts skills such as word recall and information processing. tDCS has helped individuals with Alzheimer's Disease think more clearly. In this trial, participants will receive a combination of these two methods, which might also alleviate symptoms like mood swings and agitation in Alzheimer's patients. Early results suggest this combined approach could enhance patients' quality of life by targeting specific brain areas related to these symptoms. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for veterans aged 60-85 with mild to moderate Alzheimer's or related dementia, showing neuropsychiatric symptoms. They must have a stable psychotropic medication history and a caregiver to assist them. Participants need an MMSE score of 15-23.

Inclusion Criteria

I have a caregiver willing to help with my clinic visits and treatment.

I am a veteran aged between 60 and 85.

I have significant mental health symptoms as shown by my test scores.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one week of in-clinic iTBS sessions followed by four weeks of daily at-home tDCS sessions

5 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iTBS and tDCS Combination Treatment

Trial Overview The study tests iTBS (in-clinic) and tDCS (at-home) brain stimulation methods on Alzheimer's patients over three months, aiming to reduce mood swings, apathy, and agitation while assessing the treatment's practicality for future larger studies.

How Is the Trial Designed?

Group I: Brain Stimulation Experimental Treatment 1 Intervention

Participants will receive a combination of two non-invasive brain stimulation treatments. During the first week, iTBS sessions will be administered in-clinic for five consecutive days, using magnetic pulses to target brain areas associated with neuropsychiatric symptoms. This is followed by four weeks of daily, self-administered tDCS at home, delivering a low electrical current to modulate brain activity. Participants will complete brain scans and questionnaires at various points to evaluate changes in the brain and symptom severity.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

1. imrpress.com imrpress.com/journal/JIN/21/5/10.31083/j.jin2105130/htm

Efficacy of Intermittent Theta-Burst Stimulation ... - IMR Press Conclusions: Both iTBS and tDCS in addition to cognitive training appear to improve cognitive function and quality of life of patients with PSCI, compared to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06835283

Study Details | NCT06835283 | Novel Brain Stimulation ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465570/

Effects of intermittent theta-burst stimulation on cognition ... Significant cognitive improvements were observed at week 6 in the iTBS group, indicating delayed cognitive enhancement, though no immediate ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395625005977

Effects of different non-invasive brain stimulation ... Intermittent theta-burst stimulation improved verbal episodic memory (0.55), working memory (1.17), verbal fluency (0.49), naming ability (0.75) ...

5. gpsych.bmj.com gpsych.bmj.com/content/36/6/e101166

Impact of twice-a-day transcranial direct current stimulation ... Our research indicates for the first time that twice-a-day tDCS may improve the cognitive function of patients with AD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306417/

Efficacy and Safety of Transcranial Magnetic Stimulation on ... We aim to analyze the efficacy and safety of TMS on cognition in mild cognitive impairment (MCI), Alzheimer disease (AD), AD-related dementias, and nondementia ...