Transcranial Alternating Current Stimulation for Mild Cognitive Impairment

Overseen By Melike Kahya

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: High Point University

Must not be taking: Neuro-active drugs

Disqualifiers: Major psychiatric disorders, Stroke, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 22 minutes per session

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a brain stimulation technique, transcranial alternating current stimulation (tACS), can help older adults with mild cognitive impairment (MCI) improve balance and thinking skills, particularly during multitasking. Participants will receive either real tACS or a placebo treatment. Researchers believe tACS increases brain activity in a way that could simplify daily tasks. Individuals diagnosed with MCI who can walk and stand independently are suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 it excludes those using neuro-active drugs. It's best to discuss your specific medications with the trial team.

What prior data suggests that transcranial alternating current stimulation (tACS) is safe for older adults with mild cognitive impairment?

Research has shown that transcranial alternating current stimulation (tACS) is generally safe and well-tolerated. In past studies, participants reported only a few side effects, most of which were mild, such as tingling or itching on the scalp where the electrodes were placed. No serious side effects occurred.

The treatment uses a low electric current to stimulate the brain. Safety measures control the current and ensure comfort. For example, the session begins and ends with a gradual increase and decrease of the current to enhance comfort.

Overall, tACS has been used in other studies without major problems, suggesting it is a promising and safe option for people with mild cognitive impairment who seek to improve brain activity and function. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for mild cognitive impairment?

Researchers are excited about transcranial alternating current stimulation (tACS) for mild cognitive impairment because it offers a novel approach compared to standard treatments like medications or cognitive therapies. Unlike traditional options that primarily focus on managing symptoms, tACS is non-invasive and works by applying small electrical currents to the brain to enhance neural activity, particularly targeting areas associated with cognitive functions. This technique is tailored to each individual's brain activity, potentially leading to more personalized and effective outcomes. Moreover, tACS sessions are short and well-tolerated, making them a promising alternative for individuals seeking non-pharmacological interventions.

What evidence suggests that tACS is effective for improving balance and executive function in older adults with MCI?

This trial will compare real transcranial alternating current stimulation (tACS) with sham tACS for individuals with Mild Cognitive Impairment (MCI). Research has shown that tACS might help improve thinking skills. Early studies suggested that using tACS at a specific frequency, 10 Hz, can boost a type of brain activity known as alpha waves. People with MCI often have lower levels of these alpha waves, and increasing them has been linked to better balance and improved skills like planning and multitasking. Other research indicates that tACS can help coordinate brain activity, leading to better behavior and thinking. While some debate remains, these early findings are promising for using tACS to assist people with MCI. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults aged 65-85 with Mild Cognitive Impairment (MCI). Participants should have issues with balance and multitasking. They must be able to give consent and follow the study procedures. Specific medical conditions or treatments that could interfere with the study are reasons for exclusion.

Inclusion Criteria

Able and willing to comply with all study requirements once informed consent form is signed

Understanding of the ICF will be assessed by answering specific questions

Diagnosed with cognitive impairment based on MoCA or TICS and Clinical Dementia Rating: CDR 0.5

Exclusion Criteria

Contraindications to tACS as recorded on a standardized screening questionnaire

Cut off of MOCA score <18 will be applied

Major psychiatric co-morbidity including major depressive disorder, schizophrenia, or psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial alternating current stimulation (tACS) or sham treatment tailored to peak alpha power

22 minutes per session

Multiple sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up visit #1 at 4 weeks, Follow-up visit #2 at 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tACS

Trial Overview The trial tests if transcranial alternating current stimulation (tACS) can improve balance, executive function, and brain activity in MCI patients. It compares real tACS at 10 Hz to a sham treatment over multiple sessions, checking for lasting effects up to three months post-treatment.

How Is the Trial Designed?

Group I: real tACS Experimental Treatment 1 Intervention

The investigators will administer the transcranial alternating current stimulation (tACS) intervention individually tailored to peak alpha power to the participants. This intervention will utilize 8 electrodes; electrode placement and current parameters for each electrode have been optimized using a standard brain to generate an average electric field of 0.25 V/m. To ensure adherence to current safety recommendations for tACS, optimizations will be constrained to a maximum of total injected current 4.0 mA and a max. current per electrode of 2.0 mA. Stimulation will start and end with a 60 s ramp up/down to maximize comfort and the entire session will take 22-minute. This standard approach is both well-tolerated and safe in older adults.

Group II: sham tACS Placebo Group 1 Intervention

The investigators will administer the sham tACS intervention to the participants. They will use an active sham in which very low-level alternating currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the session. Stimulation will start and end with a 60 s ramp up/down to maximize comfort and the entire session will last in 22-minutes.

Who Is Running the Clinical Trial?

High Point University

Lead Sponsor

Trials

14

Recruited

1,400+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Hebrew SeniorLife

Collaborator

Trials

52

Recruited

273,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11989800/

Effectiveness of Transcranial Stimulation on Cognitive ... tDCS showed significant improvements in global cognitive function (p < 0.001) and selective attention (p = 0.044), but not in mental flexibility ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X23017412

The impact of gamma transcranial alternating current ... The application of gamma tACS has shown promising results in the improvement of cognitive and memory processes that are impacted in patients with MCI/AD. These ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/supplement_2/241884

Transcranial Alternating Current Stimulation on Cerebral ... Conclusions: Among patients with early AD, 77.5 Hz tACS led to a lower amyloid plaque burden and better cognitive performance at 3 weeks. In the ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.087903

Efficacy of Transcranial Alternating Current Stimulation (tACS ... tACS can induce synchronization of neural networks leading to improvement in behavior and cognition. However, there's still controversy ...

5. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-024-01570-0

TRanscranial AlterNating current stimulation FOR patients ... This study aimed to clarify beneficial effects of gamma tACS on cognitive functioning in AD and to elucidate effects on hippocampal gamma oscillation activity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11040101/

Safety and feasibility of optimized transcranial direct current ... This study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07097051

Multi-session Transcranial Alternating Current Stimulation ... Through this study, we aim to gather strong evidence that tailored tACS is a promising treatment to improve cognitive and motor functions and ...

8. translationalneurodegeneration.biomedcentral.com translationalneurodegeneration.biomedcentral.com/articles/10.1186/s40035-024-00423-y

Transcranial alternating current stimulation (tACS) at gamma ... We outline the current knowledge concerning the clinical efficacy, safety, ease-of-use and cost-effectiveness of tACS on early and advanced AD.

9. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12005

TRanscranial AlterNating current Stimulation FOR patients ... This trial will evaluate the efficacy and safety of 40 Hz tACS in patients with AD, and further explore the potential mechanisms by analyzing ...