Transcranial Electrical Stimulation for Alzheimer's Disease

(tES Trial)

Overseen By Shelly Rempel-Rossum

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Parkinson's, Huntington, Bipolar, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types of brain stimulation to determine their effectiveness in improving Alzheimer's disease symptoms. It uses special devices that send tiny electrical currents to the scalp while participants engage in brain exercises. The trial compares various stimulation frequencies and types, including Transcranial Alternating Current Stimulation (tACS) and Transcranial Random Noise Stimulation (tRNS), over several weeks, with breaks in between. This trial may suit individuals who can read, write, and speak English fluently and have been diagnosed with mild to moderate cognitive impairment, as indicated by a MoCA score between 5 and 24. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in brain stimulation for Alzheimer's.

Will I have to stop taking my current medications?

The trial requires that you do not change your medication during any treatment period, which lasts 5 weeks. If you plan to change your medication, you may not be eligible to participate.

What prior data suggests that this protocol is safe for Alzheimer's patients?

Research shows that treatments like transcranial electrical stimulation (tES) are generally safe. Studies have found 30 Hz tACS to be safe, with only a few minor side effects. Similarly, 50 Hz tACS has been shown to be safe for people with Alzheimer's disease, with no major problems reported.

Existing studies also consider 70 Hz tACS safe, with minimal side effects. The same is true for 90 Hz tACS, which research shows is well-tolerated.

Transcranial Random Noise Stimulation (tRNS) is also considered safe. Studies have found few serious side effects, making it a well-tolerated option. Overall, these treatments have been tested in various studies and are safe for people, with only mild side effects like tingling or slight skin irritation, if any. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Transcranial Electrical Stimulation (TES) for Alzheimer's Disease because it offers a non-invasive approach to potentially boost brain function. Unlike traditional treatments that often focus on medication, TES uses electrical currents to directly stimulate brain activity, which could enhance cognitive abilities. This method is unique because it combines electrical stimulation with cognitive exercises, possibly enhancing the brain's ability to form new connections. Different frequencies of Transcranial Alternating Current Stimulation (tACS) and Transcranial Random Noise Stimulation (tRNS) might target specific brain processes, offering a tailored approach to treatment. This could lead to more personalized and effective interventions for individuals with Alzheimer's.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

This trial will explore various transcranial electrical stimulation techniques for Alzheimer's disease. Research has shown that transcranial alternating current stimulation (tACS) may improve thinking and memory in people with Alzheimer's. For example, studies found that using tACS at 77.5 Hz can reduce amyloid plaques, which are linked to Alzheimer's, and enhance cognitive abilities. In this trial, participants will receive tACS at different frequencies, including 30 Hz and 50 Hz, which have shown promise in boosting memory and thinking skills. Another method tested in this trial is transcranial random noise stimulation (tRNS), which some studies have found to improve memory and thinking. These treatments are being explored as non-invasive ways to help people with Alzheimer's, with early results showing potential benefits. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with dementia or Alzheimer's disease. Participants should be able to commit to a regimen of weeks with daily sessions, followed by a 12-week break between treatments. Specific inclusion and exclusion criteria are not provided but would typically involve age, stage of disease, and overall health status.

Inclusion Criteria

MoCA score between 5 and 24

Exclusion Criteria

Current substance abuse disorder

I have a history of epilepsy or seizures.

I cannot communicate well in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different transcranial electrical stimulation (tES) treatments with cognitive exercises for 4 weeks

4 weeks

Daily sessions

Wash-out

A 12-week period with no treatment to allow for wash-out between different tES treatment types

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after each treatment cycle

4 weeks

1-month follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• 30 Hz Transcranial Alternating Current Stimulation (tACS)
• 50 Hz Transcranial Alternating Current Stimulation (tACS)
• 70 Hz Transcranial Alternating Current Stimulation (tACS)
• 90 Hz Transcranial Alternating Current Stimulation (tACS)
• Transcranial Random Noise Stimulation (tRNS)

Trial Overview The study tests the effects of various transcranial electrical stimulation (tES) frequencies: 0 Hz (placebo), 30 Hz, 50 Hz, 70 Hz, and 90 Hz tACS; plus tRNS combined with cognitive exercises. It's a long-term study where each treatment type is given in random order over several weeks.

How Is the Trial Designed?

Group I: Transcranial Random Noise Stimulation (tRNS) Experimental Treatment 1 Intervention

Participants will receive active tRNS simultaneously with cognitive exercises. Optional for participants to have their choice of music playing in the background.

Group II: Transcranial Direct Current Stimulation (tDCS) Experimental Treatment 1 Intervention

Participants will receive active tDCS simultaneously with cognitive exercises. Optional for participants to have their choice of music playing in the background.

Group III: 90 Hz Transcranial Alternating Current Stimulation (tACS) Experimental Treatment 1 Intervention

Participants will receive active tACS at 90 Hz simultaneously with cognitive exercises. Optional for participants to have their choice of music playing in the background.

Group IV: 70 Hz Transcranial Alternating Current Stimulation (tACS) Experimental Treatment 1 Intervention

Participants will receive active tACS at 70 Hz simultaneously with cognitive exercises. Optional for participants to have their choice of music playing in the background.

Group V: 50 Hz Transcranial Alternating Current Stimulation (tACS) Experimental Treatment 1 Intervention

Participants will receive active tACS at 50 Hz simultaneously with cognitive exercises. Optional for participants to have their choice of music playing in the background.

Group VI: 30 Hz Transcranial Alternating Current Stimulation (tACS) Experimental Treatment 1 Intervention

Participants will receive active tACS at 30 Hz simultaneously with cognitive exercises. Optional for participants to have their choice of music playing in the background.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11210106/

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.

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

The impact of gamma transcranial alternating current ... TACS is being explored as a tool to improve cognition and memory in patient populations with mild cognitive impairment (MCI) and Alzheimer's disease (AD).

3. 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.

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

Efficacy of Transcranial Alternating Current Stimulation (tACS ... Preliminary evidence suggests the potential efficacy of tACS for improving cognition in Alzheimer's disease patients. However, due to the ...

5. 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05544201

Transcranial Alternating Current Stimulation (TACS) for ... Objectives: The investigators aim to 1) investigate and compare the safety, efficacy and sustainability of 40 Hz HD-tACS and HD-tDCS over left dorsolateral ...

7. academic.oup.com academic.oup.com/brain/article/147/12/4003/7889082

emerging field of non-invasive brain stimulation in Alzheimer's ... Transcranial alternating current stimulation (tACS), Alternating electrical current, 40 Hz, 1–2 mA, 4–6 weeks 2–5 sessions/week 30–60 min/ ...