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Search / Trial NCT03846492

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

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Feb 15, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Dementia Transcranial Magnetic Stimulation Transcranial Direct Current Stimulation T Dcs Tms Tms Eeg Mri Agitation Alzheimer's Disease Neuropsychiatric Symptoms Agitation In Dementia Mixed Dementia Non Invasive Brain Stimulation

ClinConnect Summary

This clinical trial is investigating new ways to understand and treat agitation and aggression in people with Alzheimer's disease and other types of dementia. These behaviors affect many individuals with dementia, often leading to challenges for them, their families, and caregivers. The researchers are using non-invasive techniques, like applying magnetic stimulation to the head and monitoring brain activity, to learn more about what causes these symptoms and to see if a specific treatment called transcranial direct current stimulation (tDCS) can help reduce agitation.

To participate in this study, you need to be at least 50 years old and have a diagnosis of dementia related to Alzheimer's with mild to moderate agitation. You should also have a support person who can accompany you to appointments. If you take medication for agitation, it should have been stable for at least a week. The study is currently recruiting participants, and those who join can expect to undergo brain stimulation treatments while researchers gather information to understand how these therapies might improve their symptoms. If you or someone you know might be interested, it’s a good idea to discuss it with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

  • Participants with AD+Agitation
  • Inclusion:
  • 1. Age 50 years or older.
  • 2. Participant or substitute decision maker able and willing to provide informed consent.
  • 3. Dementia due to probable or possible AD as defined by NIA-AA criteria.
  • 4. Presence of mild to moderate agitation and/or aggression as defined by: Agitation in cognitive disorders. International Psychogeriatric Association Provisional Consensus Clinical and Research Definition.
  • 5. Availability of a support person to accompany the participant to study appointments and provide collateral information as needed.
  • 6. If taking medication for neuropsychiatric symptoms, the dose should be stable for at least 1 week.
  • Exclusion:
  • 1. Psychiatric diagnosis other than dementia significantly impacting the presentation.
  • 2. Presence of delirium or other acute medical condition significantly contributing to agitation/aggression or making the study participation unsafe for a participant.
  • 3. Any contraindication to TMS or tDCS.
  • 4. Any other condition that in the opinion of principal investigator will make the study participation unsafe or non-feasible for the participant.
  • 5. Currently taking anticonvulsants or benzodiazepines at a dose sufficient to cause interference with TMS-EEG.
  • Participants with AD without aggression
  • All the above inclusion/exclusion criteria except meeting the inclusion criterion 4 pertaining to agitation/aggression. Participants with significant agitation/aggression will be excluded from this group.
  • Healthy comparator participants
  • Inclusion:
  • 1. Age 50 years or older.
  • 2. Able and willing to provide informed consent.
  • 3. Free from any significant neurological disorder.
  • Exclusion:
  • 1. Lifetime DSM-5 diagnosis other than simple phobias or adjustment disorder.
  • 2. Any Contraindication to TMS.
  • 3. Currently taking anticonvulsants or benzodiazepines at a dose sufficient to cause interference with TMS-EEG.

About Centre For Addiction And Mental Health

The Centre for Addiction and Mental Health (CAMH) is Canada’s leading mental health and addiction teaching hospital, dedicated to advancing research, clinical care, and education in the field of mental health. With a commitment to improving the lives of individuals affected by mental illness and addiction, CAMH conducts innovative clinical trials aimed at developing and evaluating new treatment approaches. The institution fosters a collaborative environment that brings together researchers, clinicians, and community partners to translate scientific findings into effective interventions, ensuring the highest standards of care and support for patients. Through its robust research initiatives, CAMH strives to enhance understanding of mental health disorders and promote evidence-based practices in the treatment of addiction and mental health challenges.

Locations

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Sanjeev Kumar, MD, FRCPC

Principal Investigator

Centre for Addiction and Mental Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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