What side effects are associated with this type of intervention?

Common treatments for dementia that involve non-invasive brain stimulation, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), generally have mild side effects. These can include headaches, scalp discomfort, tingling, lightheadedness, and in rare cases, seizures. Peripheral electrical nerve stimulation has shown minimal burden and no significant adverse effects in studies, though its efficacy remains uncertain. Overall, these treatments are considered safe with manageable side effects, but more research is needed to confirm their long-term effectiveness and safety.

What prior FDA approvals exist?

FDA-approved treatments for dementia primarily include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and the NMDA receptor antagonist memantine. These drugs aim to improve cognitive function by modulating neurotransmitter activity. While transcranial electrical stimulation (tES) and other brain stimulation techniques like transcranial magnetic stimulation (TMS) show promise in modulating neuronal activity to improve cognitive and motor functions, they are still under investigation and not yet FDA-approved for dementia treatment.

What other types of research exist?

Promising novel alternatives to tES/brain stimulation for dementia patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in improving cognitive functions; 2) Noninvasive Vagus Nerve Stimulation (nVNS), which may offer benefits in cognitive enhancement; and 3) Remote Electrical Neuromodulation, which has demonstrated efficacy in other neurological conditions and could be explored for dementia treatment.

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Non-invasive Brain Stimulation

Non-invasive Brain Stimulation for Dementia (ACDCStim Trial)

N/A

Recruiting

Led By Brad Manor, PhD

Research Sponsored by Hebrew SeniorLife

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Participants must not have blindness or other disabilities that prevent task performance

Participants must not have the presence of any active dermatological condition, such as eczema, on the scalp

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediate post-intervention, 3 month follow up, 6 month follow up

Awards & highlights

Summary

This trial tests a home-based brain stimulation treatment using gentle electrical currents to improve memory, movement, and thinking skills in older adults with early-stage memory problems. Caregivers are trained to administer the treatment at home. This method has been widely studied for its potential to enhance cognitive function in older adults, including those with neurodegenerative diseases like Alzheimer's.

Who is the study for?

This trial is for older adults with mild cognitive impairment or mild dementia who can read, write, and communicate in English. They must have a caregiver willing to learn and administer brain stimulation treatments. Participants should not have severe psychiatric disorders, major vision impairments, skin conditions on the scalp, or score below 18 on the MoCA test.

What is being tested?

The study tests if remote brain stimulation by caregivers can improve memory, mobility, and executive function in dementia patients. It involves active/sham transcranial direct current (tDCS) and alternating current (tACS) stimulations to see which combination is effective.

What are the potential side effects?

Potential side effects of tDCS/tACS may include discomfort at the electrode site on the scalp, headache, fatigue, nausea or itching during stimulation. Serious side effects are rare but could involve changes in mood or thinking.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any disabilities that stop me from performing tasks.

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I do not have any active skin conditions like eczema on my scalp.

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I, as a caregiver, can use my hands without severe pain, arthritis, or any condition that would prevent me from administering treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediate post-intervention, 3 month follow up, 6 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediate post-intervention, 3 month follow up, 6 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediate post-intervention, 3 month follow up, 6 month follow up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Dual Task Cost to Gait

Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall

Secondary study objectives

Average E-field normal component (En) for left angular gyrus and prefrontal cortex

Change in 12-item Short Form Health Survey (SF-12)

Change in Adjusted Trail Making Test performance

+7 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: tACS(AG) + tDCS(PFC) combo activeExperimental Treatment1 Intervention

Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

Group II: tACS(AG) active + tDCS(PFC) shamActive Control1 Intervention

Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

Group III: tACS(AG) sham + tDCS(PFC) activeActive Control1 Intervention

Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

Group IV: tACS(AG) sham + tDCS(PFC) shamPlacebo Group1 Intervention

Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

0 / 3Eligibility criteria met

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 dementia, such as transcranial electrical stimulation (tES) and brain stimulation, work by modulating neuronal activity to improve cognitive and motor functions. These treatments aim to enhance synaptic plasticity, increase cerebral blood flow, and stimulate neurogenesis, which can help mitigate the cognitive decline and motor dysfunction associated with dementia. This is crucial for dementia patients as it can lead to improved memory, executive functioning, and overall quality of life, potentially slowing the progression of the disease.

Alzheimer's disease: rhythm, timing and music as therapy.Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA trial.Peripheral electrical nerve stimulation and rest-activity rhythm in Alzheimer's disease.