Ignite Creation Date:
2024-05-06 @ 12:46 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03846492
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2019-02-08
Brief Title:
Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tTED
Brief Summary:
Agitation and aggression impose a tremendous burden on the individuals living with dementia their families caregivers and healthcare systems Neuropsychiatric symptoms of dementia NPS affect up to 80 of patients with Alzheimers dementia AD The mechanisms of agitation in AD are poorly understood and the current interventions are only modestly effective while having serious adverse effects In this study the investigators propose to assess the mechanisms and treatment of neuropsychiatric symptoms in AD with the use of non-invasive brain stimulation approaches By applying magnetic stimulation to the surface of the head transcranial magnetic stimulation - TMS combined with electroencephalography EEG the investigators will be able to study the mechanisms of agitation and advance our understanding of AD Further the investigators will evaluate if transcranial direct current stimulation tDCS is effective to treat agitation dementia
Detailed Description:
Alzheimers dementia AD and related neurodegenerative diseases are inflicting a global healthcare crisis Neuropsychiatric symptoms including agitation and aggression affect up to 80 of patients with AD Among these symptoms agitation and aggression are the most burdensome for patients families caregivers and the health care system The mechanisms of agitation in AD are poorly understood and the current interventions are only modestly effective while having serious adverse effects
In this study the investigators propose to assess the mechanisms and treatment of neuropsychiatric symptoms in AD with the use of non-invasive brain stimulation approaches Agitationaggression is associated with abnormalities in the balance of cortical excitationinhibition Transcranial magnetic stimulation TMS using single and paired pulse TMS paradigms such as long interval cortical inhibition LICI and short interval intracortical inhibition SICI can assess this cortical excitationinhibition balance in vivo The investigators will use TMS combined with electroencephalography EEG to assess cortical excitationinhibition balance in the dorsolateral prefrontal cortex DLPFC of participants with AD with and without agitationaggression and age matched healthy comparators
Transcranial direct current stimulation tDCS is a non-invasive brain stimulation technique that uses a very low intensity electric current to modulate cortical excitability and brain plasticity tDCS can restore excitation and inhibition balance by altering GABA and glutamate activity in the brain tDCS can be safely administered to awake persons and is very well tolerated Studies in healthy individuals and patients with AD have shown that tDCS applied to frontal brain regions can enhance cognitive function Further tDCS applied to frontal brain regions can improve depressive symptoms The effects of tDCS on neuropsychiatric symptoms are not known In this study the investigators will use tDCS applied to the frontal brain regions to target deficits in inhibition and symptoms of agitationaggression in AD
This study will be done over a period of 3 years at Centre for Addiction and Mental Health Geriatric Psychiatry Division and Temerty Centre for Therapeutic Brain Intervention The investigators will recruit and enroll 30 individuals with AD Agitation mild to moderate agitation 30 individuals with AD without agitation and 30 older healthy individuals Medical work up will be done as part of clinical care prior to study enrollment to rule out medical causes of agitation Clinical and cognitive assessments will be performed to characterize participants at baseline The investigators will assess cortical inhibition using TMS EEG at baseline in the three groups Individuals with AD agitation will then receive a 2 week course of activesham cathodal tDCS to frontal brain region in a double blind 11 randomized control design Assessment of cortical inhibition using measures identical to baseline will be done at the end of tDCS course The investigators will also repeat clinical and cognitive assessments after tDCS course and 2 weeks later Measures of cortical inhibition will first be compared between HC and AD and between AD and AD Agitation groups The treatment effects on clinical symptoms cortical inhibition and the rate adverse events will be compared between active and sham tDCS groups
During the Covid-19 pandemic the study has been modified to be administered in a hybrid manner to accommodate both in-person and virtual assessments Clinical and cognitive assessments can be done in-person or remotely The initial tDCS course will be conducted in-person with the research staff The remaining tDCS intervention will be completed onsite or at the participants home with virtual supervision from the research team
In this study the investigators propose to assess the mechanisms and treatment of neuropsychiatric symptoms in AD with the use of non-invasive brain stimulation approaches Agitationaggression is associated with abnormalities in the balance of cortical excitationinhibition Transcranial magnetic stimulation TMS using single and paired pulse TMS paradigms such as long interval cortical inhibition LICI and short interval intracortical inhibition SICI can assess this cortical excitationinhibition balance in vivo The investigators will use TMS combined with electroencephalography EEG to assess cortical excitationinhibition balance in the dorsolateral prefrontal cortex DLPFC of participants with AD with and without agitationaggression and age matched healthy comparators
Transcranial direct current stimulation tDCS is a non-invasive brain stimulation technique that uses a very low intensity electric current to modulate cortical excitability and brain plasticity tDCS can restore excitation and inhibition balance by altering GABA and glutamate activity in the brain tDCS can be safely administered to awake persons and is very well tolerated Studies in healthy individuals and patients with AD have shown that tDCS applied to frontal brain regions can enhance cognitive function Further tDCS applied to frontal brain regions can improve depressive symptoms The effects of tDCS on neuropsychiatric symptoms are not known In this study the investigators will use tDCS applied to the frontal brain regions to target deficits in inhibition and symptoms of agitationaggression in AD
This study will be done over a period of 3 years at Centre for Addiction and Mental Health Geriatric Psychiatry Division and Temerty Centre for Therapeutic Brain Intervention The investigators will recruit and enroll 30 individuals with AD Agitation mild to moderate agitation 30 individuals with AD without agitation and 30 older healthy individuals Medical work up will be done as part of clinical care prior to study enrollment to rule out medical causes of agitation Clinical and cognitive assessments will be performed to characterize participants at baseline The investigators will assess cortical inhibition using TMS EEG at baseline in the three groups Individuals with AD agitation will then receive a 2 week course of activesham cathodal tDCS to frontal brain region in a double blind 11 randomized control design Assessment of cortical inhibition using measures identical to baseline will be done at the end of tDCS course The investigators will also repeat clinical and cognitive assessments after tDCS course and 2 weeks later Measures of cortical inhibition will first be compared between HC and AD and between AD and AD Agitation groups The treatment effects on clinical symptoms cortical inhibition and the rate adverse events will be compared between active and sham tDCS groups
During the Covid-19 pandemic the study has been modified to be administered in a hybrid manner to accommodate both in-person and virtual assessments Clinical and cognitive assessments can be done in-person or remotely The initial tDCS course will be conducted in-person with the research staff The remaining tDCS intervention will be completed onsite or at the participants home with virtual supervision from the research team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None