Brain Stimulation for Memory Loss

(NACC-EC Trial)

Overseen By Amanda Chao, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rotman Research Institute at Baycrest

Must not be taking: Benzodiazepines, Hypnotics, Antidepressants, others

Disqualifiers: Psychotic disorder, Bipolar, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-7 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining accelerated deep Transcranial Magnetic Stimulation (dTMS) with cognitive training can improve memory and thinking skills in older adults with memory issues. Participants will receive either real dTMS or a sham version (placebo-like) and will engage in online cognitive exercises. The trial targets individuals aged 55-85 who are concerned about their memory and maintain a stable medication routine. Researchers will assess the safety and tolerability of this approach while collecting early data on its effects on memory. As an unphased trial, this study allows participants to contribute to innovative research that could enhance memory care for older adults.

Will I have to stop taking my current medications?

You need to be stable on your medications for at least 2 months before joining the study and should not expect to change them during the study. If you are on unstable doses of certain medications like antidepressants or memory enhancers, you may not be eligible.

What prior data suggests that this protocol is safe for older adults with cognitive decline?

Research has shown that accelerated deep Transcranial Magnetic Stimulation (dTMS) is generally safe and well-tolerated. Studies on people with depression found that these faster treatments are as safe as the standard once-a-day sessions, with no major safety issues reported.

Previous research used dTMS for conditions like Parkinson's and Alzheimer's diseases, indicating a good safety record. Accelerated dTMS targets deeper brain areas, potentially improving memory and thinking skills.

Overall, this treatment has demonstrated safety in other situations, and similar methods have been used without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatment for memory loss because it involves an innovative approach called accelerated neuromodulation of the anterior cingulate cortex. Unlike most treatments that rely on medications, this method uses targeted brain stimulation, specifically intermittent theta-burst stimulation (iTBS). This technique is believed to directly enhance neural pathways associated with memory, potentially offering quicker and more precise improvements in cognitive function. Additionally, combining this with online cognitive remediation could further boost memory performance, offering a holistic approach to managing memory loss.

What evidence suggests that this trial's treatments could be effective for memory loss?

Research has shown that deep Transcranial Magnetic Stimulation (dTMS) can improve memory by targeting specific brain areas. In this trial, participants will receive either accelerated dTMS combined with mental exercises or sham stimulation with mental exercises. In accelerated dTMS, patients experienced better thinking skills when combined with mental exercises. This method uses magnetic fields to gently stimulate the brain, potentially enhancing memory and thinking. Although still under study, early research suggests this technique could help older adults with memory issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Linda Mah, MD

Principal Investigator

Baycrest Rotman Research Institute

Are You a Good Fit for This Trial?

This trial is for older adults aged 55-85 with mild memory problems or Mild Cognitive Impairment, scoring at least 24 on the MMSE. Participants must be stable on medications, able to consent and follow the treatment schedule. Exclusions include metal in the head, unstable medical conditions, contraindications to TMS like pacemakers, certain psychiatric disorders or substance abuse history.

Inclusion Criteria

Score 24 or higher on the Mini Mental State Examination (MMSE)

Satisfactory safety screening questionnaire for TMS

Willing to provide informed consent

Exclusion Criteria

Metal plate in the head (excluding non-magnetic dental devices and implants)

Unstable medical condition(s)

Known contraindications to TMS

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 20-40 sessions of dTMS or sham stimulation over 2-5 consecutive days, followed by 6 weeks of online cognitive remediation

6-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Neuromodulation of Anterior Cingulate Cortex

Trial Overview

The study tests if accelerated deep Transcranial Magnetic Stimulation (dTMS) combined with cognitive training can improve cognition in older adults with memory issues. It compares an active Brainsway H7-Coil dTMS system against a sham version to assess safety and potential cognitive benefits.

How Is the Trial Designed?

Group I: 20-40 sessions of iTBS dTMS and 6-weeks of online cognitive remediation Experimental Treatment 1 Intervention

Group II: 20-40 sessions of sham stimulation and 6-weeks of online cognitive remediation Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rotman Research Institute at Baycrest

Lead Sponsor

Trials

11

Recruited

460+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07212504

Study Details | NCT07212504 | Effect of Accelerated ...

The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also ...

2.

trialx.com

trialx.com/clinical-trials/listings/322202/effect-of-accelerated-neuromodulation-of-anterior-cingulate-cortex-to-enhance-cognition-in-older-adults-with-mild-memory-problems/

Effect of Accelerated Neuromodulation of Anterior ...

The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07212465

Accelerated Neuromodulation of Anterior Cingulate Cortex ...

This study will investigate the effects of an accelerated intermittent theta burst protocol (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6582998/

Accelerated TMS for Depression: A Systematic Review and ...

The impact of accelerated HF-rTMS on the subgenual anterior cingulate cortex in refractory unipolar major depression: insights from 18FDG PET brain imaging.

5.

psychiatryonline.org

psychiatryonline.org/doi/10.1176/appi.ajp.2019.19070720

Stanford Accelerated Intelligent Neuromodulation Therapy ...

The authors examined the feasibility, tolerability, and preliminary efficacy of Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10523198/

Past, present, and future of deep transcranial magnetic ...

This paper reviews the clinical progress of DTMS in psychiatric and neurological disorders such as Parkinson's disease, Alzheimer's disease, post-stroke motor ...

7.

nature.com

nature.com/articles/s41386-023-01776-0

A systematic review and meta-analysis of neuromodulation ...

Studies in depression have found that accelerated protocols are safe and well-tolerated, and perform comparably to standard once-daily rTMS [151 ...

8.

med.stanford.edu

med.stanford.edu/psychiatry/news/new-funding-announcement/dtms.html

Researchers at Stanford Psychiatry Awarded Grant to ...

This study will use deep transcranial magnetic stimulation (dTMS) – a neuromodulation technique that allows for deeper stimulation of cortical ...