MedTrace Logo

Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS

NCT03846492 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-13

No results posted yet for this study

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 (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.

Conditions

  • Alzheimer Disease
  • Dementia, Mixed
  • Dementia
  • Behavior Problem
  • Dementia, Alzheimer Type

Interventions

DEVICE

Transcranial Direct Current Stimulation (tDCS)

tDCS is a non-invasive brain stimulation modality that does not require general anesthesia or surgical implantation of a device. tDCS utilizes low intensity electrical current either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode. It uses 3 AAA batteries to deliver direct current via rubber electrodes enclosed in saline soaked sponges.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

  • BrightFocus Foundation

    collaborator OTHER

Principal Investigators

  • Sanjeev Kumar, MD, FRCPC · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2025-04-08
Completion
2026-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846492 on ClinicalTrials.gov