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Brain 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

Must not have

Psychiatric diagnosis other than dementia significantly impacting the presentation

Currently taking anticonvulsants or benzodiazepines at a dose sufficient to cause interference with TMS-EEG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 weeks after baseline

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I have been diagnosed with Alzheimer's disease.

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I do not have any major neurological conditions.

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I experience mild to moderate agitation or aggression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a psychiatric condition, but it's not dementia, affecting my health.

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I am on medication for seizures or anxiety that may affect brain wave tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Long Interval Cortical Inhibition (LICI), a TMS paradigm, will be used to assess the extent of cortical inhibition

Secondary study objectives

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

back pain flair up

Myasthenia Gravis

100%

80%

60%

40%

20%

Study treatment Arm

tDCS + Robotic Arm Therapy

tDCS Sham + Robotic Arm Therapy

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

~2150

0 / 6Eligibility criteria met