Deep TMS for Mild Cognitive Impairment

(Deep MIND Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Must be taking: Psychotropic medications

Must not be taking: Bupropion, Benzodiazepines

Disqualifiers: Bipolar, Psychotic disorder, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy called deep transcranial magnetic stimulation (dTMS), which uses magnetic fields to stimulate specific brain areas. It targets older adults who have experienced a mild decline in memory or cognitive function over the past year but can still manage daily tasks independently. Participants will receive treatment using one of three different dTMS devices: the Brainsway H1-Coil, H4-Coil, or H7-Coil Deep TMS System. The trial aims to assess the effectiveness and tolerability of each device. Researchers will also monitor changes in thinking abilities, brain activity, mood, and sleep. This study represents a step toward understanding how dTMS might improve mental functions. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance cognitive health in older adults.

Will I have to stop taking my current medications?

The trial requires that participants be on stable dosages of other psychotropic medications for at least 4 weeks before screening, so you may need to adjust your current medications to meet this requirement.

What prior data suggests that these dTMS coils are safe for older adults with mild neurocognitive disorder?

Research has shown that the Brainsway H1-Coil Deep TMS System is safe and well-tolerated. It has effectively treated depression, even in individuals unresponsive to antidepressants. Notably, one study found it safe for older adults with mild memory problems, with no major side effects reported.

The H4-Coil and H7-Coil systems have also undergone safety testing. A thorough review of several studies found that serious side effects were rare. The FDA has approved the H7-Coil for treating obsessive-compulsive disorder, indicating its safety for that condition.

Overall, these findings suggest that the H1, H4, and H7 coil systems are generally safe and well-tolerated, with serious side effects being uncommon. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for mild cognitive impairment, which often include medications like cholinesterase inhibitors and lifestyle changes, Deep TMS (Transcranial Magnetic Stimulation) targets brain activity directly using magnetic fields. Researchers are excited about this technique because it can stimulate specific brain regions without the need for drugs, potentially offering a non-invasive alternative with fewer side effects. The different coils—H1, H4, and H7—each focus on unique brain areas, which might lead to more personalized and effective interventions for improving cognitive function.

What evidence suggests that this trial's treatments could be effective for mild cognitive impairment?

Research has shown that deep transcranial magnetic stimulation (dTMS) using the H1 coil, which participants in this trial may receive, may improve thinking skills in people with mild cognitive impairment (MCI). Another treatment arm in this trial involves the H4 coil, which several clinical trials have shown to be effective for various mental health conditions, though specific results for MCI remain limited. The H7 coil, also tested in this trial, targets brain areas involved in obsessive-compulsive disorder (OCD) and has received FDA approval for this purpose, suggesting it might positively affect brain function. While direct evidence for mild neurocognitive disorder is still developing, early findings for dTMS in related areas appear promising. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults aged 60-90 with mild neurocognitive disorder, evidenced by a MoCA score of 18-26 and self-reported cognitive decline. Participants must be independent in daily activities, mobile without assistance, and on stable psychotropic medications if any. Excluded are those with severe mental health issues, frequent dizziness, other neurological disorders affecting cognition, or contraindications to rTMS like metal implants or seizure history.

Inclusion Criteria

Able to provide informed consent to participate in the study

Mild impairment in cognitive performance as evidenced by a score of 18-26 on the MoCA

I feel my memory or thinking has slightly worsened over the last year.

Exclusion Criteria

Active suicidal behavior

Individuals residing beyond the borders of the Greater Hamilton Area and its neighbouring vicinities

Substance use disorder (other than tobacco use disorder) in the past 3 months before entering the study (screened via self-report)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deep transcranial magnetic stimulation (dTMS) using one of three coils (H1, H4, H7) over a six-week period, with 20 sessions in total.

6 weeks

20 visits (in-person)

Follow-up

Participants are monitored for changes in cognition, mood, and sleep through neuropsychological testing, EEG, and questionnaires.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brainsway H1-Coil Deep TMS System
• Brainsway H4-Coil Deep TMS System
• Brainsway H7-Coil Deep TMS System

Trial Overview The study tests the feasibility and tolerability of three deep TMS coils (H1, H4, H7) on cognition in older adults with mild neurocognitive disorder. It measures changes through neuropsychological testing, EEGs for brain activity, mood and sleep questionnaires before treatment midpoint and end point as well as follow-up.

How Is the Trial Designed?

Group I: Active H7-coil dTMS treatment Experimental Treatment 1 Intervention

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

Group II: Active H4-coil dTMS treatment Experimental Treatment 1 Intervention

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

Group III: Active H1-coil dTMS treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123001300

Deep TMS H1 Coil treatment for depression This study shows that beyond its proven efficacy in RCTs, Deep TMS with the H1 coil is effective for treating depression under naturalistic conditions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03665831

Deep TMS for Comorbid Depression and Cognitive ... This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients over 60 years of age ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306417/

Efficacy & Safety of TMS on Cognition: MCI, AD, ADRD, & More The reviewed studies provide favorable evidence of improved cognition with TMS across all groups with cognitive impairment. TMS was safe and ...

4. brainsway.com brainsway.com/wp-content/uploads/2023/11/DiPassa_review_2023.pdf

Clinical Efficacy of Deep Transcranial Magnetic Stimulation ... Currently, there are no effective treatment options to delay the progression of mild cognitive impairment and dementia [19], nor are there ...

5. clinicaltrial.be clinicaltrial.be/en/details/213253?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Deep TMS for Comorbid Depression and Cognitive ... This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07038798

Deep rTMS for Mild Neurocognitive Disorder in Older Adults 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4329899/

Efficacy and safety of deep transcranial magnetic ... These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, ...

8. brainsway.com brainsway.com/wp-content/uploads/2024/06/jcm-13-00816.pdf

Safety and Efficacy of Deep TMS for Late-Life Depression The goal of this phase IV study was to collect real-world post-marketing surveillance data and outcomes from patients with late-life depression ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03665831

Deep TMS for Comorbid Depression and Cognitive ... This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients over 60 years of age ...