What side effects are associated with this type of intervention?

Neuromodulation techniques like transcranial Direct Current Stimulation (tDCS) and transcranial magnetic stimulation (TMS) are being explored for Alzheimer's Disease. Common side effects of these treatments are generally mild and may include sensations such as tingling, itching, or warmth at the site of stimulation. Other potential side effects can include lightheadedness, redness, and muscle twitching. Serious adverse events are rare, but there is a theoretical risk of triggering seizures, particularly in patients with epilepsy.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on medications that manage symptoms rather than neuromodulation techniques like transcranial Direct Current Stimulation (tDCS). Approved drugs include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and an NMDA receptor antagonist (memantine). These medications aim to improve cognitive function and slow disease progression. While tDCS is being studied for its potential benefits in modulating neuronal activity, it has not yet received FDA approval for Alzheimer's Disease treatment.

What other types of research exist?

Promising novel alternatives to tDCS for Alzheimer's Disease patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells and has shown potential in improving cognitive function. 2) Deep Brain Stimulation (DBS), an invasive procedure that involves implanting electrodes in the brain to modulate neural activity, which has shown promise in preliminary trials for cognitive improvement. 3) Electroconvulsive Therapy (ECT), which has been found to improve global cognitive functioning and specific cognitive domains such as attention and processing speed in patients with cognitive impairment.

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Device

tDCS for Alzheimer's Disease

N/A

Recruiting

Led By Kendra M Anderson, PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2, week 4, week 6, 6 weeks post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment called tDCS, which uses a small electrical current to stimulate the brain. It aims to help patients with Alzheimer's Disease and Related Dementias (ADRD) who have difficult behavioral symptoms. The study will check if this treatment is safe and effective for these patients. Transcranial direct current stimulation (tDCS) has been studied for over two decades and shows potential in enhancing cognitive function in Alzheimer's disease (AD).

Who is the study for?

This trial is for individuals with Alzheimer's Disease and related dementias who show behavioral symptoms. Participants must have a caregiver willing to join the study, stable medication doses for at least one month, and be able to speak and read English. It's not suitable for those with unstable medical conditions, brain surgery history, seizures, metal in their head from past surgeries or substance abuse issues.

What is being tested?

The trial is testing home-based Transcranial Direct Current Stimulation (tDCS) on patients with Alzheimer’s-related behavioral symptoms. The goal is to see if tDCS is easy to use at home, safe for these patients, and effective in reducing their behavioral issues.

What are the potential side effects?

Potential side effects of tDCS may include mild discomfort at the stimulation site on the scalp, itching or tingling during treatment sessions, fatigue or headache after treatment. Serious side effects are rare but can include seizure or skin burns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2, week 4, week 6, 6 weeks post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 2, week 4, week 6, 6 weeks post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 4, week 6, 6 weeks post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire

safety as assessed by the side effects questionnaire

Secondary study objectives

Change in apathy as assessed by the Brief Dimensional Apathy Scale (b-DAS)

Change in cognition as evaluated by the Mini-Mental State Examination (MMSE)

Change in dementia-related behavioral symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) scale

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: active tDCSExperimental Treatment1 Intervention

All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

active tDCS

2018

N/A

~790

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, by inhibiting the enzyme that breaks it down. Memantine helps regulate glutamate, another neurotransmitter involved in learning and memory, by blocking NMDA receptors to prevent overstimulation that can lead to neuronal damage. These treatments aim to enhance or stabilize cognitive function and slow the progression of symptoms. Similar to tDCS, which modulates neuronal activity via low electrical current, these treatments are crucial as they target the underlying neurochemical imbalances and neuronal dysfunctions that characterize Alzheimer's Disease, potentially improving quality of life and cognitive abilities in patients.