40 Participants Needed

TMS for Mild Cognitive Impairment

(NetTMS Trial)

MH
SW
MM
MM
EF
Overseen ByEmily Finch, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses magnetic stimulation to target brain areas identified through MRI scans. It focuses on adults with mild cognitive impairment, aiming to improve memory by enhancing brain connectivity and function. Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve cognitive function in patients with mild cognitive impairment (MCI).

Will I have to stop taking my current medications?

The trial requires that participants do not use medications known to lower the seizure threshold or affect working memory. If you are taking such medications, you may need to stop them to participate.

Is TMS safe for humans?

Transcranial Magnetic Stimulation (TMS) has been studied in various conditions, including Alzheimer's disease and mild cognitive impairment, and is generally considered safe for humans. However, the specific safety profile can vary depending on the individual and the condition being treated, so it's important to discuss potential risks with a healthcare provider.12345

How is the treatment Network-guided TMS different from other treatments for mild cognitive impairment?

Network-guided TMS is unique because it uses brain imaging to tailor the treatment to each individual's brain network, potentially improving its effectiveness by targeting specific areas affected by mild cognitive impairment. This personalized approach is different from traditional treatments that do not account for individual brain differences.13467

What data supports the effectiveness of the treatment for mild cognitive impairment?

Research suggests that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive symptoms in people with mild cognitive impairment by altering brain network connections. This approach has shown potential in enhancing cognitive performance in conditions related to Alzheimer's disease.12346

Who Is on the Research Team?

SW

Simon W Davis, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 55-80 with mild cognitive impairment (MCI) who can consent to the study and are willing to use birth control if applicable. It's not for those with a history of substance abuse, pregnant or breastfeeding women, people with certain mental disorders, intracranial implants, pacemakers, seizure risks, significant head trauma or neurological conditions like dementia.

Inclusion Criteria

I am between 55 and 80 years old.
You have mild cognitive impairment as diagnosed by a doctor.
Use of effective method of birth control for women of childbearing capacity
See 3 more

Exclusion Criteria

You have a history of alcohol or drug addiction (except for nicotine).
I am not pregnant or breastfeeding.
I have a high risk of seizures due to conditions like epilepsy or serious head injury.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline Assessment

Participants complete neuropsychological tests and provide a saliva sample for APOE genotype determination

1 day
1 visit (in-person)

Initial MRI Scanning

Participants undergo an initial MRI scanning session to collect data for network-based targeting

1 day
1 visit (in-person)

Treatment

Participants undergo combined TMS-fMRI sessions to assess the effects of network-based TMS on memory performance

3 days
3 visits (in-person)

Follow-up

Participants are monitored for changes in neurovascular reactivity, structural connectivity, and episodic memory task performance

3 days
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Network-guided TMS
Trial Overview The trial tests a new approach using transcranial magnetic stimulation (TMS), guided by MRI brain connectivity measures. The goal is to see if TMS can improve memory in older adults with MCI compared to fake (sham) treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Network-guided TMSExperimental Treatment1 Intervention
The study comprises one arm of five sessions. In Day 1 (\~1.5 hr session), participants fill forms, complete a neuropsychological test battery (NIH Toolbox, NACC UDS, BDI), and provide a saliva sample to be banked for future APOE genotype determination. On Day 2 (\~1 hr session), subjects will perform an initial MRI scanning session. In this session, MRI, RSFA, DWI, and fMRI are collected so they can be used for network-based targeting. In Days 3-5 (each comprising a \~2.5 hr session) a few days later participants will undergo combined TMS-fMRI sessions. In the scanner, participants complete four fMRI runs: 2 runs using either a network-based or standard target location, counterbalanced across participants. Active and Sham TMS trials are intermixed within each run.

Network-guided TMS is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as rTMS for:
  • Resistant depression
  • Obsessive-compulsive disorder
  • Migraine
🇪🇺
Approved in European Union as rTMS for:
  • Depression
  • Anxiety disorders

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

This study demonstrates the feasibility of using individual resting-state fMRI to identify optimal TMS targets for Alzheimer's disease, focusing on the default mode and fronto-parietal networks, which are crucially affected in AD.
The individualized fMRI-guided TMS targeting approach showed significant differences in target localization compared to traditional methods, suggesting that personalized targeting could enhance the effectiveness of TMS treatments in Alzheimer's patients.
Functional Imaging to Guide Network-Based TMS Treatments: Toward a Tailored Medicine Approach in Alzheimer's Disease.Bagattini, C., Brignani, D., Bonnì, S., et al.[2021]
In a study of 21 patients with amnestic mild cognitive impairment (aMCI), repetitive transcranial magnetic stimulation (rTMS) significantly improved cognitive performance and altered functional connectivity within the default mode network (DMN) compared to a sham treatment.
The changes in DMN connectivity, particularly a decrease in connectivity, were linked to cognitive improvements, suggesting that baseline DMN activity could predict how well patients respond to rTMS therapy.
Repetitive Transcranial Magnetic Stimulation Induced Hypoconnectivity Within the Default Mode Network Yields Cognitive Improvements in Amnestic Mild Cognitive Impairment: A Randomized Controlled Study.Cui, H., Ren, R., Lin, G., et al.[2020]
Neuro-navigated rTMS applied to the left angular gyrus significantly improved cognitive performance in patients with amnestic mild cognitive impairment and Alzheimer's disease, indicating its potential as a therapeutic intervention.
The study found that changes in brain network connectivity, particularly in higher-order cognitive networks, could predict individual responses to rTMS treatment, suggesting a personalized approach to therapy based on baseline brain dynamics.
Functional network connectivity patterns predicting the efficacy of repetitive transcranial magnetic stimulation in the spectrum of Alzheimer's disease.Chen, H., Li, M., Qin, Z., et al.[2023]

Citations

Functional Imaging to Guide Network-Based TMS Treatments: Toward a Tailored Medicine Approach in Alzheimer's Disease. [2021]
Repetitive Transcranial Magnetic Stimulation Induced Hypoconnectivity Within the Default Mode Network Yields Cognitive Improvements in Amnestic Mild Cognitive Impairment: A Randomized Controlled Study. [2020]
Functional network connectivity patterns predicting the efficacy of repetitive transcranial magnetic stimulation in the spectrum of Alzheimer's disease. [2023]
Cortical excitability and plasticity in Alzheimer's disease and mild cognitive impairment: A systematic review and meta-analysis of transcranial magnetic stimulation studies. [2022]
Altered Cortical Synaptic Plasticity in Response to 5-Hz Repetitive Transcranial Magnetic Stimulation as a New Electrophysiological Finding in Amnestic Mild Cognitive Impairment Converting to Alzheimer's Disease: Results from a 4-year Prospective Cohort Study. [2023]
Chronic treatment with rivastigmine in patients with Alzheimer's disease: a study on primary motor cortex excitability tested by 5 Hz-repetitive transcranial magnetic stimulation. [2015]
Targeting the pathological network: Feasibility of network-based optimization of transcranial magnetic stimulation coil placement for treatment of psychiatric disorders. [2023]
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