Using brain stimulation to treat agitation in dementia patients

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

This study is testing if brain stimulation techniques can help reduce agitation and aggression in older adults with Alzheimer's disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Centre for Addiction and Mental Health (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT03846492 on ClinicalTrials.gov

What this trial studies

This study investigates the use of non-invasive brain stimulation techniques, specifically transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), to understand and treat neuropsychiatric symptoms such as agitation and aggression in patients with Alzheimer's dementia. By assessing the balance of cortical excitation and inhibition in the brain, the researchers aim to identify mechanisms underlying these symptoms and evaluate the effectiveness of tDCS in reducing agitation. Participants will include individuals aged 50 and older with mild to moderate agitation associated with Alzheimer's disease, and the study will involve both brain stimulation and electroencephalography (EEG) assessments.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older diagnosed with Alzheimer's disease who exhibit mild to moderate agitation or aggression.

Not a fit: Patients with psychiatric diagnoses other than dementia or those with acute medical conditions contributing to agitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of agitation and aggression in dementia patients, enhancing their quality of life.

How similar studies have performed: Other studies using non-invasive brain stimulation techniques have shown promise in treating neuropsychiatric symptoms, suggesting potential for success in this approach.

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.

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Sanjeev Kumar, MD, FRCPC — Centre for Addiction and Mental Health
• Study coordinator: Gifty Asare, MSc

Conditions: Alzheimer Disease, Dementia, Mixed, Dementia, Behavior Problem, Dementia, Alzheimer Type, Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation, tDCS