Recruiting

H1 vs. H4 vs. H7

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT07038798

Conditions

Mild Neurocognitive Disorder

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Brainsway H1-Coil Deep TMS System

Brainsway H4-Coil Deep TMS System

Brainsway H7-Coil Deep TMS System

Study Details

Brief summary:

This study aims to: (1) assess the feasibility and tolerability of three deep transcranial magnetic stimulation (dTMS) coils H1, H4, and H7 in older adults with mild neurocognitive disorder (mild NCD); and (2) evaluate changes in cognition through neuropsychological testing, brain activity through EEG, and mood and sleep through self-report questionnaires. Participants will be assigned to one of three arms: H1- coil vs. H4-coil vs. H7-coil, and all participants will complete assessments examining dTMS side effects, mental health symptoms, and cognition. EEG, questionnaires, and CNS vital signs will be measured at baseline, midpoint (after 10th session- before dTMS treatment on visit 11), and end point, as well as follow up. Collectively, the study will address the absolute and differential feasibility and tolerability of the H1, H4 and H7 coils to provide preliminary data for a future randomized controlled trial comparing this novel intervention to a sham stimulation (placebo) control.

Conditions

Mild Neurocognitive Disorder

Study ID

NCT07038798

Start date

Aug 26, 2025

Status verified date

May, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 60 - 90 years old
  • Able to provide informed consent to participate in the study
  • Subjective concern of mild decline in cognitive function over the past year
  • Mild impairment in cognitive performance
  • Preserved independence in everyday activities
  • Independently mobile (e.g., participants must be able to get in and out of a chair on their own)
  • Participants will be required to be on stable dosages of other psychotropic medications for at least 4 weeks prior to screening

Exclusion Criteria:

  • Currently receiving treatment or subjective need for treatment for bipolar I or II disorder; psychotic disorder
  • Active suicidal behavior
  • Severe depression and/or anxiety
  • Other neurological or psychiatric disorders accounting for the cognitive deficits
  • Impairment in basic and/or instrumental activities of daily living
  • Substance use disorder (other than tobacco use disorder) in the past 3 months before entering the study
  • Traditional contraindications to rTMS: Intracranial or metal implants in the head or nearby regions, excluding the mouth, that cannot be safely removed; History of epilepsy or seizures; Active unstable medical condition (recent laboratory and neuroimaging alterations, delirium); Pacemaker and/or implantable cardioverter-defibrillators; current use of bupropion, treatment with equivalent benzodiazepine dose to lorazepam >2 mg/day
  • People with severe literacy, visual, or hearing issues that affect the ability to engage in the interviews
  • People with recurring migraines or headaches (weekly or more)
  • Frequent dizziness/vertigo
  • Individuals residing beyond the borders of the Greater Hamilton Area and its neighbouring vicinities

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active H1-coil dTMS treatment

This arm will receive dTMS treatment through active H1-coil.

experimental: Active H4-coil dTMS treatment

This arm will receive dTMS treatment through active H4-coil.

experimental: Active H7-coil dTMS treatment

This arm will receive dTMS treatment through active H7-coil.

Interventions

Brainsway H1-Coil Deep TMS System

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H1-coil.

Brainsway H4-Coil Deep TMS System

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H4-coil.

Brainsway H7-Coil Deep TMS System

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H7-coil.

Primary outcome measure

  • Feasibility criteria 1: Protocol completion [ Time Frame: 6 weeks ]
  • Feasibility criteria 2: Retention rate [ Time Frame: 6 weeks ]
  • Feasibility criteria 3: Screening rates and capacity [ Time Frame: 6 weeks ]
  • Feasibility criteria 4: Recruitment rate and capacity [ Time Frame: 6 weeks ]
  • Feasibility criteria 5: Duration of intervention and assessment processes [ Time Frame: 6 weeks ]
  • Feasibility criteria 6: Safety of H-coil dTMS treatment [ Time Frame: 6 weeks ]
  • Tolerability of H-coil dTMS treatment [ Time Frame: 6 weeks ]

Central Contacts and Locations

Locations

Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L9C 0E3

Contacts

Jane De Jesus, BSc

905-522-1155dejesuj@mcmaster.ca

Dante Duarte, MD, MSc, PhD

905 522-1155duartedante@mcmaster.ca

Principal Investigator:

Dante Duarte, MD, MSc, PhD

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Oct 6, 2025

Last verified

May, 2025

Keywords

  • Mild Neurocognitive Disorder
  • Mild NCD
  • Mild Cognitive Impairment
  • Deep Transcranial Magnetic Stimulation
  • deep TMS
  • dTMS
  • H coil
  • H-coil
  • H1-coil
  • H4-coil
  • H7-coil

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2025-10-06.