rTMS for Apathy Clinical Trial

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Apathy in Dementia; Dementia; Mild Behavioural Impairment; Mild Cognitive Impairment; Neurocognitive Disorders
• Interventions: Device: rTMS; Drug: methylphenidate

• Registration Number: NCT05561205
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

Apathy is a common, early, and disabling symptom in dementias and mild behavioural impairment such as Alzheimer's disease (AD) and is characterized by lack of interest and enthusiasm. Both repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, and methylphenidate, a medication, have been shown to improve apathy. This pilot study will investigate rTMS as a treatment for apathy in neurocognitive disorders and mild behavioural impairment in individuals receiving methylphenidate and individuals not receiving medication for apathy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-09-30
• Study Start: 2023-02-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• mild or major neurocognitive disorder OR mild behavioural impairment
• Apathy for at least 4 weeks
• Stable dose of medication (>4 weeks) that may affect cognition or behaviour
• Care partner who spends at least 10 hours a week with the subject

Exclusion Criteria

• Current major depressive episode
• Agitation, delusions, hallucination
• Medical contraindications to rTMS
• Currently taking an amphetamine product
• Central nervous system abnormalities, Tourette's syndrome, or motor tics
• Current participation in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS only	rTMS	repetitive transcranial magnetic stimulation (rTMS) only
rTMS + methylphenidate	rTMS	repetitive transcranial magnetic stimulation (rTMS) and methylphenidate
rTMS + methylphenidate	methylphenidate	repetitive transcranial magnetic stimulation (rTMS) and methylphenidate

Primary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory-apathy	2 weeks	Measure of apathy on a scale from 0 to 12 with a higher score indicating greater apathy

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada