Investigational Dementia Treatment Study

NCT05203523 | Completed FDA Device

• 1 other identifier: HS25171(B2021:089)
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

This research investigates the effect of active versus sham tACS paired with cognitive exercises in a regimen protocol of weeks, everyday. The study design is a one-time crossing over design in which participants are randomized into two groups: One group will receive active treatment for 4 weeks, then 8 weeks of no treatment followed by another 4 weeks of treatment but with sham. The other group will start with sham and end up with active treatment. The study is double-blind; thus, neither participants, nor the assessors know the group assignment. The Intervention is applying tACS either active or sham paired with cognitive exercises (MindTriggers app games). Note: The above study will run at both University of Manitoba (U of M) and Aster Gardens residence. However, at Aster Gardens Residence only questionnaire type of assessments will be run, while in U of M, the investigators will have three other major assessments as well. In addition, the investigators will run the assessments at the Aster Gardens Residence through online sessions.

Conditions

Dementia, Mild

Outcome Measures

Primary Outcomes (1)

• Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five, eleven and sixteen weeks.

  Cognitive and memory task that focus on 6 major memory indexes: Auditory Memory, Visual Memory, Visual Working Memory, Immediate Memory, Delayed Memory, and Recognition Memory.

  Baseline (week 0), week 5, week 11, week 16

Secondary Outcomes (6)

• N-back test

  Baseline (week 0), week 5, week 11, week 16

• Neuropsychiatric Inventory Questionnaire (NPIQ)

  Baseline (week 0), week 5, week 11, week 16

• Functional Near Infrared Spectroscopy (fNIRS)

  Baseline (week 0), week 5, week 11, week 16

• Electrovestibulography (EVestG)

  Baseline (week 0), week 5, week 11, week 16

• Virtual Reality Navigation (VRN) spatial orientation test

  Baseline (week 0), week 5, week 11, week 16

Study Arms (2)

Group 1 (G1)

EXPERIMENTAL

Participants will receive active tACS simultaneously with cognitive exercises.

Device: transcranial alternative current stimulation (tACS); Other: cognitive exercises

Group 2 (G2)

SHAM COMPARATOR

Participants will receive sham tACS simultaneously with cognitive exercises.

Other: cognitive exercises

Interventions

transcranial alternative current stimulation (tACS) DEVICE

A light electrical current will be applied to the scalp of the participants via 2 electrodes, while the participants performs cognitive exercises with the guidance of a trained research assistant.

Group 1 (G1)

cognitive exercises OTHER

Participant will perform memory and learning games/tasks through "Mind Triggers" app on an IPad. Participants will be guided by a highly trained research assistant.

Group 1 (G1); Group 2 (G2)

Eligibility Criteria

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

You may qualify if:

• ability to read, write and speak English fluently

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
• Plan to change the medication during this study's period

Sponsors & Collaborators

• University of Manitoba: lead
• Riverview Health Centre Foundation: collaborator
• Charis Senior Residences LP. DBA Aster Gardens: collaborator

Study Sites (2)

Aster Gardens

Edmonton, Alberta, Canada

Location

Riverview Health Centre

Winnipeg, Manitoba, R3L 2P4, Canada

Location

Related Publications (1)

• Jacobson N, Lithgow B, Jafari Jozani M, Moussavi Z. The Effect of Transcranial Alternating Current Stimulation With Cognitive Training on Executive Brain Function in Individuals With Dementia: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 27;11(4):e37282. doi: 10.2196/37282.

  PMID: 35475789 DERIVED

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The group assignment is known only by the study coordinator and the PI. Group assignment will be randomized into either Group 1 or Group 2 using PROC PLAN procedure of SAS randomization. The group assignment of a participant could potentially be unblinded on compassionate ground (e.g., if a participant comes from a different city for the duration of the study) or request of the participant or any emergency situation (although very rare). In that case the participant's data may be excluded from the analysis totally or depending on when this unblinding occur, half of the data might be usable for analysis (if unblinding occur during the waiting period before crossing over). The unblinding decision will be made by the PI.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept. of Electrical and Computer Eng. Director Biomedical Engineering

Model Details: This human research study is a crossover, placebo controlled and double-blind study. It will have two groups of subjects matched in age, and sex and cognitive level (measured by Montreal Cognitive Assessment: MoCA). Group 1 (G1) participants will receive active tACS simultaneously with cognitive exercises. Group 2 (G2) participants will receive sham tACS simultaneously with cognitive exercises. The volunteers who cannot tolerate application of tACS and focus on the cognitive exercises at the same time, will be enrolled in a third group (G3); they will receive only cognitive exercises with the same protocol as in G1 and G2. We will use only two periods design (one time crossing over).

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: January 24, 2022
• Study Start: January 24, 2022
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: March 13, 2025

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)