Investigating Different Frequencies of Transcranial Electrical Stimulations in Dementia Population

NCT06547021 | Recruiting FDA Device

• 1 other identifier: HS26590 (B2024:091)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Dementia is a prevalent condition with no known cure. It affects not only the person with dementia but also the family. This study will investigate the effects of applying different transcranial electrical stimulation (tES) waveforms to find the optimal stimulation when paired with cognitive exercise on older adults with dementia. It is a placebo-controlled double-blind study with statistical rigor. In addition, the investigators will investigate technological methods to monitor changes due to the intervention. These include functional near infrared spectroscopy (fNIRS), electroencephalography (EEG), electrovestibulography (EVestG), and balance measurements using accelerometers. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention. EEG measures the electrical activity of the brain via electrodes placed on the scalp to study the brain's response to different electrical stimulations treatments. EVestG is a non-invasive measure of the vestibuloacoustic system in both background (no motion) and in response to passive whole-body tilt stimuli. We hypothesize there is a direct link between vestibular system deficiencies and Alzheimer's. Lastly, the investigators will measure the effects of electrical stimulation on balance by measuring postural sway using two accelerometers. This study investigates the effects of transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS) with different protocols for frequencies to determine the most effective treatment to improve cognitive abilities and working memory for people with dementia. The global objective of the proposed study is to investigate the effects of different tES in improving the cognitive status of older adults with dementia, when paired simultaneously with cognitive training. The general objectives include the following:

1. 1.Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor.
2. 2.Investigate the correlation of fNIRS outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictivity to the treatment at baseline.
3. 3.Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline.
4. 4.Investigate the effects of different tES on balance for older adults with cognitive impairment.
5. 5.Investigate the correlation of EVestG outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictively to the treatment at baseline.
6. 6.Disseminate the project results and design the next follow up project.

Conditions

Dementia

Keywords

transcranial electrical stimulation

Outcome Measures

Primary Outcomes (2)

• Alzheimer's Disease Assessment Scale (ADAS-Cog)

  11 tasks include the participant completing tests and observer based assessments. It assesses cognitive domains of memory, language and praxis. The score ranges from 0 to 70 where higher score indicates greater cognitive impairment.

  For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)

• Wechsler Memory Scale (WMS-IV)

  Cognitive and memory task that focuses on 6 major memory indexes: auditory memory, visual working memory, immediate memory, delayed memory, and recognition memory. The score ranges from 40 to 160 where the lower score indicates greater cognitive impairment.

  For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)

Secondary Outcomes (12)

• Neuropsychiatric Inventory Questionnaire (NPI-Q)

  For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)

• Functional Near Infrared Spectroscopy (fNIRS)

  For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)

• EEG power in theta band

  For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9), and pre- and post-treatment EEG for 3 treatments days

• EEG power in gamma band

  For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)

Study Arms (6)

Transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

Participants will receive tDCS simultaneously with cognitive exercises for one month every day excluding weekends.

Device: Transcranial Direct Current Stimulation (tDCS)

Gamma Transcranial Alternating Current Stimulation (tACS)

EXPERIMENTAL

Participants will receive personalized gamma tACS simultaneously with cognitive exercises for one month every day excluding weekends.

Device: Gamma Transcranial Alternating Current Stimulation (tACS)

Theta Transcranial Alternating Current Stimulation (tACS)

EXPERIMENTAL

Participants will receive personalized theta tACS simultaneously with cognitive exercises for one month every day excluding weekends.

Device: Theta Transcranial Alternating Current Stimulation (tACS)

Sham Stimulation

EXPERIMENTAL

Participants will receive sham stimulation simultaneously with cognitive exercises for one month every day excluding weekends.

Device: Sham

Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus

EXPERIMENTAL

Participant will receive tACS at the personalized gamma over the regular placement of electrodes (left dorsolateral prefrontal cortex and the reference electrode on the contralateral supraorbital area) for the first 30-min training session and then over the precuneus (one electrode over Pz on the 10-20 EEG system and the other over the right deltoid muscle) during the second 30-min training session.

Device: Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus

Bilateral DLPFC

EXPERIMENTAL

Applying the optimal tES over left and right DLPFC. First 30-min will target the left DLPFC similar to the other arms, and the second 30-min treatment will target tES to the right DLPFC (one electrode over right DLPFC and one electrode over contralateral supraorbital area).

Device: Bilateral DLPFC

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

A light electrical current with zero frequency (tDCS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.

Transcranial Direct Current Stimulation (tDCS)

Gamma Transcranial Alternating Current Stimulation (tACS) DEVICE

A light electrical current with personalized gamma frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.

Gamma Transcranial Alternating Current Stimulation (tACS)

Theta Transcranial Alternating Current Stimulation (tACS) DEVICE

A light electrical current with personalized theta frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.

Theta Transcranial Alternating Current Stimulation (tACS)

Sham DEVICE

Sham stimulation (i.e. only slight stimulation at the beginning and at the end for a few seconds with majority of the time having no stimulation) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.

Sham Stimulation

Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus DEVICE

A light electrical current with personalized gamma frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.

Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus

Bilateral DLPFC DEVICE

A light electrical current applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. First 30-min treatment will target left DLPFC and second 30-min treatment will target right DLPFC. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.

Bilateral DLPFC

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MoCA score between 5 and 24
• Between the age of 50 and 95 years old

You may not qualify if:

• Being diagnosed with Parkinson's, Parkinsonian dementia, Huntington disease, speech significant aphasia and intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder.
• Having a History of epileptic seizures or epilepsy
• Inability to adequately communicate in English
• Impaired vision or hearing severe enough to impair performance in cognitive tests
• Current substance abuse disorder
• Currently participating in another therapeutic study for dementia
• Change to medication for Alzheimer's disease, dementia, or depression

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Riverview Health Centre

Winnipeg, Canada

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Shelly Rempel-Rossum

CONTACT

204-789-3389; Shelly.rempelrossum@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The order of treatments is only known by the study coordinator, the PI and the supervisor. The order of treatments will be randomized.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive all 4 treatments in a randomized order with washout period of 2-5 months. After finishing all 4 treatments, participants receive one more treatment protocol after the washout period where the participant will receive tACS at the personalized gamma over the regular placement of electrodes (left dorsolateral prefrontal cortex and the reference electrode on the contralateral supraorbital area) for the first 30-min training session and then over the precuneus (one electrode over Pz on the 10-20 EEG system and the other over the right deltoid muscle) during the second 30-min training session. Once they complete the Pz protocol, participants will receive their optimal treatment with the first 30-min targeting the left DLPFC and the second 30-min targeting the right DLPFC (one electrode over right DLPFC and one over contralateral supraorbital area).

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-08

Locations

CA (1)