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Behavioural Intervention

Transcranial Magnetic Stimulation for Memory Improvement

N/A

Recruiting

Led By David E Warren, PhD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

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

Must have

Healthy adults without history of psychiatric or neurological disease OR previous diagnosis of amnestic MCI

Adults 19 years of age and older

Must not have

Individuals who have increased intracranial pressure

Individuals with any neurological disorder other than aMCI (e.g., stroke, traumatic brain injury)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up potential changes will be assessed after each one-week rtms treatment period. results will be reported at the end of the study (approximately one year).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether transcranial magnetic stimulation (TMS) can improve memory in healthy adults (young and old) and treat memory deficits in older adults with amnestic mild cognitive impairment (aMCI), which often precedes Alzheimer's disease.

Who is the study for?

This trial is for adults over 19, either healthy or with mild memory issues (aMCI), who can follow instructions and sit still for tests. They must be right-handed and speak English natively. It's not for those with metal implants (except dental), major illnesses, substance abuse problems, seizures, other neurological disorders, or pregnant women.

What is being tested?

The study is testing if targeted brain stimulation using rTMS can improve memory in healthy young and older adults as well as those with aMCI by affecting brain network connectivity related to memory.

What are the potential side effects?

rTMS is generally considered safe but may cause discomfort at the stimulation site, headache, lightheadedness, or rare seizures.

Eligibility Criteria

Inclusion Criteria

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

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I am a healthy adult with no psychiatric or neurological diseases, or I have been diagnosed with amnestic MCI.

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I am 19 years old or older.

Exclusion Criteria

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

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I have high pressure inside my skull.

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I have aMCI but no other neurological disorders like stroke or brain injury.

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I have a major medical condition like cancer, HIV, hepatitis, or heart disease.

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I have epilepsy, a history of seizures, or take medication that could lower my seizure threshold.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ potential changes will be assessed after each one-week rtms treatment period. results will be reported at the end of the study (approximately one year).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~potential changes will be assessed after each one-week rtms treatment period. results will be reported at the end of the study (approximately one year).

This trial's timeline: 3 weeks for screening, Varies for treatment, and potential changes will be assessed after each one-week rtms treatment period. results will be reported at the end of the study (approximately one year). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in memory performance measured with the number of studied face-word associations recalled

Secondary study objectives

Changes in intrinsic functional connectivity between the target brain region stimulated with rTMS and other brain regions.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Sham then StimulationExperimental Treatment1 Intervention

All procedures are identical in both arms with the exception of the order of stimulation administration. In Arm B, sham stimulation will be applied in the first week of participation, and transcranial magnetic stimulation (TMS) will be applied in the second week of participation.

Group II: Arm A: Stimulation then ShamExperimental Treatment1 Intervention

All procedures are identical in both arms with the exception of the order of stimulation administration. In Arm A, transcranial magnetic stimulation (TMS) will be applied in the first week of participation, and sham stimulation will be applied in the second week of participation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial magnetic stimulation

2015

Completed Phase 4

~590

0 / 6Eligibility criteria met