rTMS for Apathy Clinical Trial

NCT ID: NCT05561205

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2025-12-01

Brief Summary

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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

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Conditions

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Alzheimer Disease Apathy in Dementia Dementia Mild Behavioural Impairment Mild Cognitive Impairment Neurocognitive Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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rTMS + methylphenidate

repetitive transcranial magnetic stimulation (rTMS) and methylphenidate

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

repetitive transcranial magnetic stimulation

methylphenidate

Intervention Type DRUG

methylphenidate

rTMS only

repetitive transcranial magnetic stimulation (rTMS) only

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

repetitive transcranial magnetic stimulation

Interventions

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rTMS

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

methylphenidate

methylphenidate

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Carla Zucchero-Sarracini

Role: primary

416-480-6100 ext. 63185

Other Identifiers

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SUN-5342

Identifier Type: -

Identifier Source: org_study_id

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