What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) for Mild Cognitive Impairment (MCI) is generally well-tolerated, with the most common side effects being mild and transient. These include scalp discomfort or pain at the stimulation site, headaches, and muscle twitching. Serious adverse events are rare but can include seizures, particularly in individuals with a history of epilepsy. Other treatments for MCI, such as cholinesterase inhibitors (e.g., donepezil), may cause gastrointestinal issues, dizziness, and cardiovascular effects. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Mild Cognitive Impairment (MCI) mentioned in the provided context. However, treatments similar to Network-based Transcranial Magnetic Stimulation (TMS), such as single-pulse TMS, have shown efficacy in other conditions like episodic migraine and depression. These treatments modulate brain activity through targeted magnetic pulses and have been studied for their potential to enhance cognitive functions, including memory.

What other types of research exist?

Promising novel alternatives to Network-based Transcranial Magnetic Stimulation (TMS) for Mild Cognitive Impairment (MCI) patients include Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving cognitive functions in various neurological conditions, and Remote Electrical Neuromodulation (REN), which has demonstrated efficacy in alleviating episodic migraine pain and may have potential applications in cognitive enhancement. Both methods are non-invasive and have been subjects of recent clinical research.

← Back to Search

Neuromodulation

TMS for Mild Cognitive Impairment (NetTMS Trial)

N/A

Recruiting

Led By Simon W Davis, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elderly: age between 55-80

Be older than 18 years old

Must not have

Women who are pregnant or breast feeding

Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, increased intracranial pressure, or history of significant head trauma with loss of consciousness for ≥ 30 minutes.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during 3 followup sessions (day 2, day 3, day 4)

Awards & highlights

No Placebo-Only Group

Summary

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).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of TMS may include discomfort at the stimulation site, headache, lightheadedness, risk of seizure in susceptible individuals and other less common symptoms such as hearing loss if ear protection isn't used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 55 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breastfeeding.

Select...

I have a high risk of seizures due to conditions like epilepsy or serious head injury.

Select...

I have no history of major neurological disorders.

Select...

I do not have dementia, Huntington's disease, or multiple sclerosis.

Select...

I am taking medication that could affect my memory or increase seizure risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 3 followup sessions (day 2, day 3, day 4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during 3 followup sessions (day 2, day 3, day 4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during 3 followup sessions (day 2, day 3, day 4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Episodic Memory Task Performance (accuracy and response time)

Change in neurovascular reactivity, as measured by resting-state fluctuations in activity (RSFA)

Change in structural connectivity, as measured by fractional anisotropy (FA)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Magnetic Stimulation (TMS) is a common treatment for Mild Cognitive Impairment (MCI) that uses targeted magnetic pulses to stimulate specific brain regions, potentially enhancing memory and cognitive functions. This non-invasive method directly influences neural activity and connectivity, offering a promising approach to improve cognitive deficits in MCI patients. Understanding these mechanisms is crucial for developing effective interventions to slow or reverse cognitive decline.