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

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ClinicalTrials.gov Identifier: NCT03846492

Recruitment Status : Recruiting

First Posted : February 19, 2019

Last Update Posted : August 15, 2019

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Sponsor:

Collaborator:

BrightFocus Foundation

Information provided by (Responsible Party):

Sanjeev Kumar, Centre for Addiction and Mental Health

Study Design

Study Type : Interventional (Clinical Trial) Estimated Enrollment : 90 participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Individuals with AD + agitation will receive a 2 week course of active/sham cathodal tDCS to frontal brain region in a double blind 1:1 randomized control design. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS Actual Study Start Date : April 24, 2019 Estimated Primary Completion Date : June 2022 Estimated Study Completion Date : June 2022

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Posted: Sunday, November 24, 2019 9:08 PM

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https://clinicaltrials.gov/ct2/show/NCT03846492?term=pulsed+brain&cond=Alzheimer+Disease&draw=3#contacts

Experimental: Active tDCS

The direct current will be delivered at 2 mA intensity via rubber electrodes in saline- soaked sponges for 30 min per day for 2 weeks, 5 days/week. Inhibitory stimulation will be delivered to the frontal lobes.

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.

Sham Comparator: sham tDCS

Sham tDCS will use the same parameters except that the device will automatically turn off after a certain duration.

Intervention Model Description: Individuals with AD + agitation will receive a 2 week course of active/sham cathodal tDCS to frontal brain region in a double blind 1:1 randomized control design.