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Investigating a Novel Brain Stimulation Treatment for Mild Alzheimer's Disease

Investigating the effect of a novel brain stimulation treatment on episodic memory and gamma activity in Mild Alzheimer's Disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000010190
Enrollment
30
Registered
2019-01-08
Start date
2019-05-15
Completion date
2022-02-10
Last updated
2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a randomised controlled trial involving 50 patients with mild Alzheimer’s disease (aged 50-85), that aims to investigate the efficacy of Transcranial Alternating Current Stimulation (tACS), a gentle non-invasive brain stimulation technique, in reducing symptoms of Alzheimer’s. Patient and carer experience with the tACS treatment will also be examined. Participants will be randomised to either active or placebo tACS, and will receive 20 treatment sessions over four-weeks. Clinical symptoms, cognition and quality of life will be assessed pre-treatment, at the end of the treatment course, and at 6 week and 3 month follow-ups. At the conclusion of the study, participants who initially received placebo tACS will be given the option of receiving active treatment.

Interventions

Transcranial Alternating Current (tACS) is a form of non-invasive brain stimulation that delivers a weak electrical current that alternates at a specified frequency back and forth between electrodes. The tACS device in this trial consists of a purpose-built handheld battery driven unit that delivers a current controlled voltage across an active and reference electrode. The active and reference electrodes are placed within commercially supplied saline soaked sponges, held in place using a custom

Transcranial Alternating Current (tACS) is a form of non-invasive brain stimulation that delivers a weak electrical current that alternates at a specified frequency back and forth between electrodes. The tACS device in this trial consists of a purpose-built handheld battery driven unit that delivers a current controlled voltage across an active and reference electrode. The active and reference electrodes are placed within commercially supplied saline soaked sponges, held in place using a custom designed headset such that the active electrode will be positioned over the left DLPFC and the reference electrode will be positioned over the right supraorbital space. Configuration of the headset to ensure correct electrode placement will be conducted by researchers at the beginning of the participant’s first tACS session. Electrode placement on the headset will then be clearly marked to ensure accurate and replicable positioning for future sessions. tACS treatment course: The tACS treatment course is a 4 week program where participants will undergo 20 sessions (daily weekday sessions Mon-Fri for four weeks) of 40 Hz gamma tACS stimulation applied at 0.057mA/cm2 peak to peak for 20 minutes per session. First, participants will attend the research centre with their nominated caregiver/support person for their baseline assessment, tACS training and their first stimulation session. This will allow researchers to observe and confirm correct self-administration of tACS. Following this, for the remainder of the treatment course participants will self-administer tACS in their own homes with remote monitoring by researchers (this will include videoconferencing where required, to be determined on a case by case basis by the PI) and assistance from their nominated caregiver/support person if required. Researchers will contact participants by phone at the end of their stimulation session each day to confirm adherence (this will also be checked via the stimulator software at the end of the treatment course) and to discuss any adverse events. If at any time participants required additional instruction for the self-administration of tACS, researchers will arrange for them to come back into the research centre for additional training and treatment observation until the researchers are satisfied they are able to self-administer (determined via the use of a published training checklist).

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

-Aged between 50-85 years -Demonstrated ability to give informed consent -Diagnosis of probable AD according to the National Institute of Neurological and Communication Disorders–Alzheimer’s Disease and Related Disorders Association (NINCDS–ADRDA) criteria -Meet criteria for mild AD as indicated by a score of greater than 19 on the Mini-Mental State Evaluation (MMSE) -Not on a cholinesterase inhibitor or memantine or have been on a stable dose for at least two months prior to screening -Not on psychotropic medication or their dose of psychotropic medication has been unchanged for a minimum of 4 weeks prior to entry into the study -Frequent contact with a caregiver who can provide information on the participant’s cognitive and functional abilities at study visits and assist with at home stimulation procedures where required -Able to participate in cognitive testing in English

Exclusion criteria

-Concomitant major and unstable medical, psychiatric or neurological illness -Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026