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Deep rTMS for Mild Neurocognitive Disorder in Older Adults

ConditionMild Neurocognitive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorSt. Joseph's Healthcare Hamilton

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brainsway H1-Coil Deep TMS System

    Device

    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

    Device

    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

    Device

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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Active H1-coil dTMS treatmentExperimental treatment 1 intervention
Group B: Active H4-coil dTMS treatmentExperimental treatment 1 intervention
Group C: Active H7-coil dTMS treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility criteria 1: Protocol completion

Percentage of intervention sessions completed

Time frame
6 weeks
2

Feasibility criteria 2: Retention rate

Percentage of participants who complete study once enrolled

Time frame
6 weeks
3

Feasibility criteria 3: Screening rates and capacity

Number of participants (n) screened; n enrolled as a percentage of n screened monthly

Time frame
6 weeks
4

Feasibility criteria 4: Recruitment rate and capacity

Total number of participants recruited and enrolled per month.

Time frame
6 weeks

Secondary outcomes

1

Changes from baseline on the Everyday Memory Questionnaire (EMQ)

The Everyday Memory Questionnaire (EMQ) is a 28-item self-report tool, that will be used to assess the frequency and impact of everyday memory problems. It will be measured at baseline (V1), midpoint (after 10th session - before deep TMS treatment on V11) and end point, as well as follow-up.

Time frame
6 weeks + one-month follow-up
2

Changes from baseline in Neurocognitive Performance measured by the CNS Vital Signs Test Battery

The CNS Vital Signs is the name of a standardized computerized neurocognitive test battery and not a set of physiological vital signs like heart rate or blood pressure. The assessments within CNS Vital Signs are cognitive domains such as memory, executive function, processing speed, etc., not physiological measurements. It will be measured at baseline (V1), midpoint (after 10th session - before deep TMS treatment on V11) and end point, as well as follow-up.

Time frame
6 weeks + one-month follow-up
3

Change from baseline on the Hamilton Depression Rating Scale- 24 item (HDRS-24).

Symptoms of depression will be assessed with the HDRS- 24 item (a 24-item depression checklist) at multiple visits: at baseline (V1), midpoint (after 10th session - before deep TMS treatment on V11) and end point, as well as follow-up.

Time frame
6 weeks + one-month follow-up
4

Change from baseline on the General Anxiety Disorder- 7 item (GAD-7)

Symptoms of anxiety will be assessed using this 7-item questionnaire at baseline (V1), midpoint (after 10th session - before deep TMS treatment on V11) and end point, as well as follow-up. Scores of 0-4 indicate minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; and 15 or greater: severe anxiety.

Time frame
6 weeks + one-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Joseph's Healthcare Hamilton

Lead sponsor

Source ClinicalTrials.gov
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