rTMS for Apathy Clinical Trial

NCT05561205 | Recruiting

• 1 other identifier: SUN-5342
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Apathy; Alzheimer's disease; Neurocognitive disorder; Mild behavioural impairment

Outcome Measures

Primary Outcomes (1)

• Neuropsychiatric Inventory-apathy

  Measure of apathy on a scale from 0 to 12 with a higher score indicating greater apathy

  2 weeks

Study Arms (2)

rTMS + methylphenidate

EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS) and methylphenidate

Device: rTMS; Drug: methylphenidate

rTMS only

EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS) only

Device: rTMS

Interventions

rTMS DEVICE

repetitive transcranial magnetic stimulation

rTMS + methylphenidate; rTMS only

methylphenidate DRUG

methylphenidate

rTMS + methylphenidate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction; Neurocognitive Disorders; Lethargy

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders; Cognition Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: February 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CA (1)