← Back to Search

Brain Stimulation

Transcranial Direct Current Stimulation (tDCS) for Alzheimer's Dementia (tTED Trial)

N/A
Recruiting
Led By Sanjeev Kumar, MD, FRCPC
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50 years or older
Dementia due to probable or possible AD as defined by NIA-AA criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 weeks after baseline
Awards & highlights

tTED Trial Summary

This trial will study the mechanisms and treatment of neuropsychiatric symptoms in Alzheimer's dementia (AD) with the use of transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG). The investigators will also evaluate if transcranial direct current stimulation (tDCS) is effective to treat agitation dementia.

Who is the study for?
This trial is for individuals aged 50 or older with Alzheimer's dementia who experience agitation. They must have a stable dose of neuropsychiatric medication if they're taking any, and cannot be on certain drugs like anticonvulsants or benzodiazepines that interfere with the study. Participants need informed consent and a support person to attend appointments.Check my eligibility
What is being tested?
The study tests non-invasive brain stimulation methods (TMS-EEG and tDCS) to understand and treat agitation in Alzheimer's dementia. It aims to explore the underlying mechanisms of these symptoms using magnetic stimulation combined with EEG, as well as assess the effectiveness of tDCS treatment.See study design
What are the potential side effects?
Potential side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures (rare). tDCS might cause skin irritation under the electrode, tingling sensation during administration, fatigue or nausea.

tTED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.
Select...
I have been diagnosed with Alzheimer's disease.
Select...
I do not have any major neurological conditions.
Select...
I experience mild to moderate agitation or aggression.

tTED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long Interval Cortical Inhibition (LICI), a TMS paradigm, will be used to assess the extent of cortical inhibition
Secondary outcome measures
Assess GABA and glutamate levels using Magnetic Resonance Spectroscopy (MRS)
Assess brain structure using Magnetic Resonance Imaging (MRI)
Assess resting state connectivity using Functional Magnetic Resonance Imaging (fMRI)
+6 more

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673
3%
back pain flair up
3%
Myasthenia Gravis
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS + Robotic Arm Therapy
tDCS Sham + Robotic Arm Therapy

tTED Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
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.
Group II: sham tDCSPlacebo Group1 Intervention
Sham tDCS will use the same parameters except that the device will automatically turn off after a certain duration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~2100

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,354 Total Patients Enrolled
BrightFocus FoundationOTHER
4 Previous Clinical Trials
338 Total Patients Enrolled
Sanjeev Kumar, MD, FRCPCPrincipal InvestigatorCentre for Addiction and Mental Health
2 Previous Clinical Trials
49 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability to participate in this clinical experiment?

"Affirmative. According to information on clinicaltrials.gov, this scientific trial is actively seeking candidates; it was initially posted on April 24th 2019 and most recently updated November 12th 2021. 90 volunteers are needed for the single participating medical site."

Answered by AI

How many participants are being monitored in this clinical experiment?

"Affirmative, clinicaltrials.gov lists this trial as in the process of enrolling participants and it was initially posted on April 24th 2019. Last updated on November 12th 2021, it is seeking 90 test subjects across one research site."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS
Sanjeev Kumar 2019. "Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03846492.
All > Alzheimer Disease > Dementia
~13 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top