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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can see and hear well enough to take psychological tests.
Select...
I am not pregnant, breastfeeding, or able to become pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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Who is running the clinical trial?
Maria I. Lapid, M.D.Lead Sponsor
Maria I LapidPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can see and hear well enough to take psychological tests.I haven't had TMS, ECT, or any brain stimulation treatments in the last year.I am not taking any medications known to cause seizures.I have had a stroke before.My thinking and memory skills are generally good.I have someone who can come with me to all my study visits.I or someone close to me has noticed my memory getting worse.I have noticed a decline in my memory for my age.I cannot communicate in English.I have a history of epilepsy or seizures.I have a condition or take medication that could increase my risk of seizures.I am in good health overall.I am not pregnant, breastfeeding, or able to become pregnant.I meet the safety requirements for TMS treatment.My medications have not changed in the last 4 weeks.I have had a brain tumor or lesion.I have been diagnosed with a major mood disorder in the last year.I am experiencing symptoms of depression.I have untreated or poorly managed sleep disorders like sleep apnea, REM sleep behavior disorder, or restless legs syndrome.I have been diagnosed with mild cognitive impairment.I can do most of my daily activities on my own.
Research Study Groups:
This trial has the following groups:- Group 1: iTBS rTMS Vertex then Lateral Parietal Cortex (LPC)
- Group 2: iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC)
- Group 3: iTBS rTMS Vertex only
- Group 4: iTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then Vertex
- Group 5: iTBS rTMS Lateral Parietal Cortex (LPC) then Vertex
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the population engaged in this clinical trial?
"Correct. According to clinicaltrials.gov, the research project is actively searching for participants and was first posted on August 11th 2022. It was last modified on August 31st 2022 with a goal of enrolling 25 patients from one site."
Answered by AI
Are participants aged 35 and above eligible to join this experiment?
"This clinical trial adheres to strict age qualifications, with a lower limit of 55 years old and an upper cap at 90."
Answered by AI
Is it possible to participate in this trial?
"This clinical trial requires 25 participants, aged 55 to 90 years old, that have been diagnosed with mild cognitive impairment (MCI). Additional criteria for inclusion include fluency in the English language; a neurological diagnosis from an expert clinician; neuropsychological testing confirming MCI; self-reported or informant-reported subjective cognitive decline; objectively assessed memory lapses relative to age group norms; largely maintained general cognitive function and daily activities without meeting dementia criteria. Additionally, eligibility must be established through transcranial magnetic stimulation safety protocols."
Answered by AI
Is the recruitment phase for this trial still underway?
"Affirmative. Clinicaltrials.gov displays evidence that this clinical trial, which was initially posted on August 11th 2022, is actively searching for participants. The medical study requires 25 volunteers from a single site to be recruited."
Answered by AI
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