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

NCT03638284 | Completed

• 1 other identifier: 099/2017
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dementia; Alzheimer, Mixed Type (Etiology)

Keywords

Dementia; neuropsychiatric symptoms; tDCS; Transcranial direct current stimulation; Alzheimer Disease; Mixed Dementia; agitation in dementia; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• The rate of successful completion of the 2 week tDCS treatment course and rates of treatment associated adverse effects of tDCS in agitation due to NPSD

  This will be assessed by the successful completion of the intervention in at least 80% of participants without any treatment associated serious adverse effects

  2 weeks

Secondary Outcomes (4)

• Effects of a 2 week course of tDCS on agitation as assessed by Cohen Mansfield Agitation Inventory (CMAI).

  2 weeks, 4 weeks

• Effects of a 2 week course of tDCS on agitation as assessed by Neuropsychiatric Inventory (NPI).

  2 weeks, 4 weeks

• Effects of a 2 week course of tDCS on agitation and other neuropsychiatric symptoms related to dementia as assessed by Clinical Global Impression (CGI).

  2 weeks, 4 weeks

• Effect of tDCS on caregiver burden in agitation due to NPSD as assessed by Zarit Burden Interview (ZBI)

  2 weeks

Study Arms (1)

Transcranial Direct Current Stimulation

EXPERIMENTAL

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.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

tDCS is a non-invasive brain stimulation that does not require general anaesthesia or surgical implantation of a device. It uses two AA size batteries to deliver direct current via rubber electrodes enclosed in saline soaked sponges.

Transcranial Direct Current Stimulation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Mixed Dementias; Aberrant Motor Behavior in Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Sanjeev Kumar, MD, FRCPC

  CAMH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/a-open label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Head of Geriatric Clinical Research, Centre for Addiction and Mental Health; Clinician Scientist and Staff Psychiatrist, Campbell Family Mental Health Research Institute; Assistant Professor of Psychiatry, University of Toronto.

Model Details: All enrolled study participants will receive 10 sessions (5 per week X 2 weeks) of tDCS in an open label study. Participants will have neurocognitive assessments at baseline and at study completion (i.e. the last day of receiving tDCS).

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 20, 2018
• Study Start: July 5, 2018
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)