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

Trial Summary

What is the purpose of this trial?

This research investigates the effect of different frequencies of tACS (0 Hz, 30 Hz, 50 Hz, 70 Hz, 90 Hz) and tRNS with cognitive exercises in a regimen protocol of weeks, everyday. The study design is a longitudinal study design in which participants receive different tES randomly ordered. Treatments occur for 4 weeks, then 12 weeks of no treatment (wash-out period), repeated for each tES treatment type. Participants have the option of having their choice of music in the background while they perform cognitive exercise.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+