Ignite Creation Date:
2024-05-06 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03638284
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2018-07-13
Brief Title:
Non-invasive Brain Stimulation Using Transcranial Direct Current Stimulation for Neuropsychiatric Symptoms of Dementia
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Non Invasive Brain Stimulation for Treatment of Neuropsychiatric Symptoms of Dementia an Open Label Pilot Study Using Transcranial Direct Current Stimulation
Status:
COMPLETED
Status Verified Date:
2024-09
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:
None
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 These symptoms impair patient and care givers quality of life increase the chances of hospitalization and also result in faster progression of the illness The efficacy of current treatments is limited and the antipsychotic medications commonly used to treat these symptoms are associated with serious side effects 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 be safely administered to awake persons and is very well tolerated In this study the investigators will use tDCS to treat agitation related to NPSD
Detailed Description:
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 These symptoms include aggression and agitation anxiety depression hallucinations and delusions These symptoms impair patient and care givers quality of life increase the chances of hospitalization and also result in faster progression of the illness The efficacy of current treatments is limited and the antipsychotic medications commonly used to treat these symptoms are associated with serious side effects including cerebrovascular events falls and increased risk of death Electroconvulsive Therapy may be effective as well however it requires anaesthesia and adversely affects cognition Non-pharmacological or behavioral interventions are universally recognized as the first line treatment for agitation and NPSD They are most effective when individualized and delivered in a person centered approach 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 be safely administered to awake persons and is very well tolerated Studies in healthy individuals and patients with Alzheimers disease 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 NPSD are not known In this study the investigators will use tDCS to treat agitation related to NPSDThe objective of this proposal is to conduct an open label pilot study of tDCS for treatment of agitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None