What side effects are associated with this type of intervention?

Common treatments for Mild Cognitive Impairment (MCI) that are similar to tACS include transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). The known side effects of TMS can include mild discomfort at the stimulation site, headache, scalp pain, and in rare cases, seizures. tDCS side effects are generally mild and may include itching, tingling, redness at the site of stimulation, and mild headache. Both treatments are considered safe with no serious long-term adverse effects reported.

What other types of research exist?

Promising novel alternatives to tACS for Mild Cognitive Impairment patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown efficacy in various neurological conditions. 2) Vagus Nerve Stimulation (VNS), a technique that involves stimulating the vagus nerve and has been studied for its potential cognitive benefits. 3) Remote Electrical Neuromodulation (REN), which involves non-invasive electrical stimulation and has shown promise in alleviating migraine pain, suggesting potential cognitive benefits. These alternatives are non-invasive and have demonstrated safety and efficacy in clinical studies.

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tACS + Cognitive Exercises for Dementia (tACS Trial)

Q: What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Mild Cognitive Impairment (MCI). However, some treatments for Alzheimer's disease, such as cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine), are sometimes used off-label for MCI. Neuromodulation techniques like Transcranial Magnetic Stimulation (TMS) have shown promise in clinical trials for various cognitive disorders, but they are not yet FDA-approved for MCI. Transcranial Alternating Current Stimulation (tACS) is an investigational treatment that modulates brain activity and is currently being studied for its potential benefits in cognitive impairment.

N/A

Recruiting

Research Sponsored by University of Manitoba

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

Diagnosis of Parkinson's, Parkinsonian dementia, Huntington disease, significant aphasia, intellectual disability, major depression, anxiety, bipolar disorder, schizophrenia or any other major mood disorder

Inability to adequately communicate in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), week 5, week 11, week 16

Summary

This trial tests a treatment that uses small electrical currents to stimulate the brain while participants play brain-training games. It targets older adults with cognitive decline to see if this approach can improve their brain function.

Who is the study for?

This trial is for English-speaking individuals with dementia or mild cognitive impairment. It's not suitable for those with Parkinson's, major mood disorders, epilepsy, severe vision/hearing issues, substance abuse disorder, or those in another dementia study. Participants shouldn't plan to change medications during the study.

What is being tested?

The trial tests transcranial alternative current stimulation (tACS) combined with cognitive exercises using an app. Participants are split into two groups; one starts with active tACS and ends with sham treatment after a break period while the other group does the opposite sequence.

What are the potential side effects?

Potential side effects of tACS may include discomfort at electrode sites, headache, fatigue or dizziness post-treatment. Cognitive exercises might cause mental fatigue but generally have minimal risks.

Eligibility Criteria

Exclusion Criteria

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

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I have been diagnosed with a neurological or major mood disorder.

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I cannot communicate well in English.

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I have a history of epilepsy or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), week 5, week 11, week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), week 5, week 11, week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), week 5, week 11, week 16 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 from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five, eleven and sixteen weeks.

Secondary study objectives

Electrovestibulography (EVestG)

Functional Near Infrared Spectroscopy (fNIRS)

N-back test

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 (G1)Experimental Treatment2 Interventions

Participants will receive active tACS simultaneously with cognitive exercises.

Group II: Group 2 (G2)Placebo Group1 Intervention

Participants will receive sham tACS simultaneously with cognitive exercises.

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

Neuromodulation techniques like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are common treatments for Mild Cognitive Impairment (MCI). TMS uses magnetic fields to induce electrical currents in specific brain regions, enhancing or inhibiting neuronal activity. tDCS applies a low electrical current to the scalp, modulating neuronal excitability. These methods aim to improve cognitive functions by altering brain activity patterns, which is crucial for MCI patients as they experience cognitive decline. By targeting brain areas involved in memory and executive functions, these treatments can potentially slow down the progression of MCI and improve quality of life.