Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547021
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Investigating Different Frequencies of Transcranial Electrical Stimulations in Dementia Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Effect of Different Frequencies of Transcranial Electrical Stimulations Paired with Cognitive Training on the Executive Brain Functions in Dementia Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 brains 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 Alzheimers 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 Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor
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 Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline
4 Investigate the effects of different tES on balance for older adults with cognitive impairment
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 Disseminate the project results and design the next follow up project
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 Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor
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 Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline
4 Investigate the effects of different tES on balance for older adults with cognitive impairment
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 Disseminate the project results and design the next follow up project
Detailed Description:
About 100 participants with either mild cognitive impairment MCI or a probable early or moderate dementia type excluding Parkinsonian dementia as confirmed by their treating physician will be recruited and tested over the course of this study
Participants will have the option to choose to do the stimulation and cognitive exercise from home or at Riverview Health Centre However all assessments will be completed at Riverview Health Centre One of the main limitations of human research is the small sample size as recruitment and enrollment of eligible participants especially in dementia population is a major challenge Thus a longitudinal study Each participant will receive all 4 tES protocols in a randomized order while playing cognitive exercises
1 Personalized gamma tACS
2 Personalized theta tACS
3 tDCS zero frequency
4 Sham tES The protocol for all tES treatments will be 4 weeks 5 daysweek excluding weekends two 30-min training sessionsday with 15 to 30 min break in between all tutored either in-person or virtually Participants will be assessed the week before each new treatment block within a week of post-treatment and a month after the end of treatment block follow-up Between the different tES treatment protocols 8-week to 20-week washout period will take place with no treatment A timeline of the treatments and washout period can be found in the table below The time period for each participant to receive all 4 protocols will be around one year and a half depending on the duration of the washout period After the participant completes all 4 protocols the investigators will offer the treatment type any of the above 4 experimental types with the highest efficacy for each participant In other words the investigators will offer an optimized treatment after the one year and a half
The eligibility criteria for enrolling individuals into this study are 50 yage95 y 5MoCA24
Exclusion criteria are any of the followings
Being diagnosed with Parkinsons Parkinsonian dementia Huntington disease speech significant aphasia and intellectual disability major depressionanxiety 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
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 Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor
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 Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline
4 Investigate the effects of different tES on balance for older adults with cognitive impairment
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 Disseminate the project results and design the next follow up project
Participants will have the option to choose to do the stimulation and cognitive exercise from home or at Riverview Health Centre However all assessments will be completed at Riverview Health Centre One of the main limitations of human research is the small sample size as recruitment and enrollment of eligible participants especially in dementia population is a major challenge Thus a longitudinal study Each participant will receive all 4 tES protocols in a randomized order while playing cognitive exercises
1 Personalized gamma tACS
2 Personalized theta tACS
3 tDCS zero frequency
4 Sham tES The protocol for all tES treatments will be 4 weeks 5 daysweek excluding weekends two 30-min training sessionsday with 15 to 30 min break in between all tutored either in-person or virtually Participants will be assessed the week before each new treatment block within a week of post-treatment and a month after the end of treatment block follow-up Between the different tES treatment protocols 8-week to 20-week washout period will take place with no treatment A timeline of the treatments and washout period can be found in the table below The time period for each participant to receive all 4 protocols will be around one year and a half depending on the duration of the washout period After the participant completes all 4 protocols the investigators will offer the treatment type any of the above 4 experimental types with the highest efficacy for each participant In other words the investigators will offer an optimized treatment after the one year and a half
The eligibility criteria for enrolling individuals into this study are 50 yage95 y 5MoCA24
Exclusion criteria are any of the followings
Being diagnosed with Parkinsons Parkinsonian dementia Huntington disease speech significant aphasia and intellectual disability major depressionanxiety 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
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 Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor
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 Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline
4 Investigate the effects of different tES on balance for older adults with cognitive impairment
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 Disseminate the project results and design the next follow up project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None