Non-invasive Brain Stimulation Using Transcranial Direct Current Stimulation for Neuropsychiatric Symptoms of Dementia

C

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Dementia; Alzheimer, Mixed Type (Etiology)

Treatments

Device: Transcranial Direct Current Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03638284
099/2017

Details and patient eligibility

About

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 Alzheimer's dementia. These symptoms impair patient and care giver's 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.

Full 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 Alzheimer's dementia. These symptoms include aggression and agitation, anxiety, depression, hallucinations, and delusions. These symptoms impair patient and care giver's 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 Alzheimer's 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 NPSD.The objective of this proposal is to conduct an open label pilot study of tDCS for treatment of agitation.

Enrollment

13 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A clinical diagnosis of Dementia of Alzheimer's, or Mixed type.
  • Presence of agitation and/or aggression related to NPS as defined by: Agitation in cognitive disorders; International Psychogeriatric Association Provisional Consensus Clinical and Research Definition at the time of enrolment into the study.
  • Patient or Substitute Decision Maker (SDM) able and willing to provide consent for enrolment in the study.
  • Age 60 or above

Exclusion criteria

  • Having dementia other than Alzheimer's or Vascular or Mixed type.
  • DSM-5 Axis I diagnoses other than dementia that is thought to be significantly impacting the presentation such as bipolar disorder, major depressive disorder, or schizophrenia
  • Imminent safety risk that would interfere with safe conduct of the study.
  • Any contraindication to tDCS such as metal implants in cranium.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Transcranial Direct Current Stimulation
Experimental group
Description:
Transcranial Direct Current Stimulation (tDCS):All enrolled study participants will receive 10 sessions (5 per week X 2 weeks) of tDCS in an open label study. Inhibitory stimulation will be delivered to the frontal lobes.
Treatment:
Device: Transcranial Direct Current Stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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