Longitudinal Study to Investigate Different Treatment Protocols of Transcranial Electrical Stimulation for Individuals With Dementia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Manitoba
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Alzheimer's Disease Assessment Scale (ADAS-Cog)
Study Overview
Brief Summary
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 4 weeks, everyday (Monday to Friday). 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 exercises.
Detailed Description
This research will investigate the effect of applying transcranial electrical stimulation (tES) with different parameters when paired with cognitive exercises with optional background music on older adults in a longitudinal study. In addition, the researchers will investigate and explore novel technological methods not only to monitor the plausible changes due to intervention. Since most technological interventions on dementia have a demanding and costly protocol, it would be of great interest to personalized optimum treatment strategy. The investigators will use Egocentric Spatial Assessment using our Virtual Reality Navigation (VRN) and functional near infrared spectroscopy (fNIRS) measurements and analysis to develop the monitoring technologies. VRN measures how people orient themselves in a non-familiar environment; the investigators hypothesize that it is deteriorated significantly in Alzheimer's disease even at its onset. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ability to read, write and speak English fluently
- •MoCA score between 5 and 24
Exclusion Criteria
- •Being diagnosed with Parkinson's disease, 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 any treatment period (5 weeks including the pre-post assessments)
Arms & Interventions
Transcranial Direct Current Stimulation (tDCS)
Participants will receive active tDCS simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Intervention: Transcranial Direct Current Stimulation (tDCS) (Device)
30 Hz Transcranial Alternating Current Stimulation (tACS)
Participants will receive active tACS at 30 Hz simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Intervention: 30 Hz Transcranial Alternating Current Stimulation (tACS) (Device)
50 Hz Transcranial Alternating Current Stimulation (tACS)
Participants will receive active tACS at 50 Hz simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Intervention: 50 Hz Transcranial Alternating Current Stimulation (tACS) (Device)
70 Hz Transcranial Alternating Current Stimulation (tACS)
Participants will receive active tACS at 70 Hz simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Intervention: 70 Hz Transcranial Alternating Current Stimulation (tACS) (Device)
90 Hz Transcranial Alternating Current Stimulation (tACS)
Participants will receive active tACS at 90 Hz simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Intervention: 90 Hz Transcranial Alternating Current Stimulation (tACS) (Device)
Transcranial Random Noise Stimulation (tRNS)
Participants will receive active tRNS simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Intervention: Transcranial Random Noise Stimulation (tRNS) (Device)
Outcomes
Primary Outcomes
Alzheimer's Disease Assessment Scale (ADAS-Cog)
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Change from baseline ADAS-Cog at 5 and 9 weeks. It consists of 11 tasks that include the subject completing tests and observer based assessments. It assesses cognitive domains of memory, language and praxis.
Wechsler Memory Scale (WMS-IV)
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five and nine 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.
Alzheimer's Disease Assessment Scale (ADAS-Cog)
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Change from baseline ADAS-Cog at 5 and 9 weeks. It consists of 11 tasks that include the subject completing tests and observer based assessments. It assesses cognitive domains of memory, language and praxis.
Wechsler Memory Scale (WMS-IV)
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five and nine 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.
Secondary Outcomes
- N-Back(For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9))
- Neuropsychiatric Inventory Questionnaire (NPIQ)(For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9))
- Functional Near Infrared Spectroscopy (fNIRS)(For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9))
- Virtual Reality Navigation (VRN) spatial orientation test(For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9))
Investigators
Dr. Zahra Kazem-Moussavi
Professor, Dept. of Electrical and Computer Eng.
University of Manitoba