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Repetitive Transcranial Magnetic Stimulation

rTMS for Mild Cognitive Impairment

N/A
Recruiting
Led By Maria I Lapid
Research Sponsored by Maria I. Lapid, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate visual and auditory abilities to complete neuropsychological testing
Not pregnant, lactating, or of childbearing potential
Must not have
Medications associated with seizures (Examples: Analgesics - Opioids (e.g., meperidine, tramadol); Anti-amyloid immunotherapy such as aducanumab; Antimicrobials - Carbapenems (e.g., imipenem), Cephalosporins (fourth generation), Fluoroquinolones (e.g., ciprofloxacin), Isoniazid, Penicillins; Hypoglycemic agents; Immunosuppressants - Azathioprine, Cyclosporine, Mycophenolate, Tacrolimus; Psychiatric medications - Antipsychotics, Atomoxetine, Bupropion, Buspirone, Lithium, Monoamine oxidase inhibitors; Pulmonary drugs - Aminophylline, Theophylline; Stimulants - Amphetamines, Methylphenidate; Sympathomimetics and decongestants - Anorexiants (e.g., diethylpropion, phentermine, nonprescription diet aids), Phenylephrine, Pseudoephedrine.)
History of stroke, including hemorrhagic stroke and ischemic stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks

Summary

This trial is testing whether a treatment called iTBS rTMS can improve memory in adults with mild cognitive impairment.

Who is the study for?
This trial is for adults with mild cognitive impairment (MCI) who speak English fluently, have been diagnosed by a neurologist, show memory issues but not severe enough to be dementia, and are in good health. They must not be pregnant or planning pregnancy, should have stable medication use for the past month, and need a care partner for study visits.
What is being tested?
The trial tests intermittent theta burst stimulation (iTBS) using repetitive transcranial magnetic stimulation (rTMS) on adults with MCI. It aims to see if this treatment is doable and can improve memory functions in participants.
What are the potential side effects?
While specific side effects of iTBS rTMS aren't listed here, common ones from similar treatments include headache, scalp discomfort at the site of stimulation, lightheadedness, or risk of seizure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can see and hear well enough to take psychological tests.
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I am not pregnant, breastfeeding, or able to become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications known to cause seizures.
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I have had a stroke before.
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I cannot communicate in English.
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I have a history of epilepsy or seizures.
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I have a condition or take medication that could increase my risk of seizures.
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I have had a brain tumor or lesion.
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I have been diagnosed with a major mood disorder in the last year.
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I am experiencing symptoms of depression.
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I have untreated or poorly managed sleep disorders like sleep apnea, REM sleep behavior disorder, or restless legs syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinician Referrals
Participant enrollment
Treatment adherence

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC)Experimental Treatment1 Intervention
Subjects will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days in the first treatment period, complete a washout period of 4 weeks then receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the DLPFC.
Group II: iTBS rTMS Vertex then Lateral Parietal Cortex (LPC)Experimental Treatment1 Intervention
Subjects will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days in the first treatment period, complete a washout period of 4 weeks then receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the LPC.
Group III: iTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then VertexExperimental Treatment1 Intervention
Subjects will receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the DLPFC in the first treatment period, complete a washout period of 4 weeks then receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days.
Group IV: iTBS rTMS Lateral Parietal Cortex (LPC) then VertexExperimental Treatment1 Intervention
Subjects will receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the LPC in the first treatment period, complete a washout period of 4 weeks then receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days.
Group V: iTBS rTMS Vertex onlyPlacebo Group1 Intervention
Cognitively normal and healthy controls will receive 1 session of iTBS rTMS for 3.5 minutes daily over the vertex for 10 consecutive days. The vertex serves as a control as there are no functional improvements in cognition with stimulation of the vertex region.

Find a Location

Who is running the clinical trial?

Maria I. Lapid, M.D.Lead Sponsor
Maria I LapidPrincipal InvestigatorMayo Clinic

Media Library

iTBS rTMS (Repetitive Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05327257 — N/A
Mild Cognitive Impairment Research Study Groups: iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC), iTBS rTMS Vertex then Lateral Parietal Cortex (LPC), iTBS rTMS Vertex only, iTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then Vertex, iTBS rTMS Lateral Parietal Cortex (LPC) then Vertex
Mild Cognitive Impairment Clinical Trial 2023: iTBS rTMS Highlights & Side Effects. Trial Name: NCT05327257 — N/A
iTBS rTMS (Repetitive Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327257 — N/A
~1 spots leftby Jan 2025