iTBS rTMS in Mild Cognitive Impairment

August 23, 2023 updated by: Maria I. Lapid, M.D.

A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI)

The purposes of this research are to test whether it is feasible to administer a treatment protocol called intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) in adults with mild cognitive impairment (MCI), and to test whether iTBS rTMS treatments can improve memory in mild cognitive impairment (MCI).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To test the feasibility of conducting a 10-day Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) protocol twice using a cross-over design in individuals with Mild Cognitive Impairment (MCI), pilot test the study protocol to assess study design, and collect pilot data on the effect of stimulations over 3 different brain regions (left dorsolateral prefrontal cortex (DLPFC), lateral parietal cortex (LPC), vertex) on working memory, new-learning and executive function in MCI. Neuropsychological and sleep measures, functional brain magnetic resonance imaging (fMRI), high density EEG and questionnaires will be performed at 5 timepoints - baseline, post-treatment after first period of 10 daily iTBS rTMS sessions, post-washout period of 4 weeks, post-treatment after cross-over to second period of 10 daily iTBS rTMS sessions, and 4 weeks follow-up post-treatment.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Must speak English fluently

  • Diagnosis of MCI as defined by:

    • Clinical diagnosis by a neurologist
    • Neuropsychological testing support of MCI
    • Meet criteria for MCI
    • Subjective cognitive decline reported by participant and/or an informant
    • Objective memory impairment in one or more cognitive domains for age
    • Essentially preserved general cognitive function
    • Largely intact functional activities
    • Does not meet criteria for dementia as judged by a clinician
  • Eligible for transcranial magnetic stimulation (TMS) based on safety criteria
  • Clinical Dementia Rating=0.5
  • Geriatric Depression Scale score less than 6
  • Medically stable and in good general health
  • Not pregnant, lactating, or of childbearing potential
  • Stable medication regimen for at least 4 weeks prior to baseline visit
  • Adequate visual and auditory abilities to complete neuropsychological testing
  • Ability to provide informed consent
  • Have a care partner who is available to accompany the participant to study visits for the duration of the protocol.

Exclusion Criteria

  • Inability to communicate in the English language
  • Meet criteria for dementia

  • Contraindications to TMS or MRI, including patients who have

    • conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments or jewelry)
    • active or inactive implants, including deep brain stimulators, cochlear implants, vagus nerve stimulators or implanted device leads
  • Any true positive findings on the TMS safety screening form
  • Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within the past 12 months
  • History of epilepsy or seizures

  • Medical conditions that increase risk of seizures

    • History of traumatic brain injury
    • History of intracranial mass or lesion
    • History of stroke, including hemorrhagic stroke and ischemic stroke

  • Psychiatric disorders

    • Primary psychotic disorder (schizophrenia, schizoaffective, or schizophreniform disorder), any history
    • Primary mood disorder (major depressive disorder, bipolar disorder) within the past 12 months
    • Substance use disorder (except caffeine and nicotine) within the past 12 months

  • Active symptoms of depression, anxiety, mania, psychosis, or substance use (except caffeine and nicotine) within the past year

    • Active symptoms of depression will be identified based on geriatric depression scale ≥ 6
    • Other active symptoms of psychiatric conditions to be determined by study investigators
  • Sleep disorders that are considered clinically significant and not sufficiently treated by the investigative team, including untreated obstructive sleep apnea (apnea-hypopnea index >15), untreated/suboptimally treated REM sleep behavior disorder, untreated/suboptimally treated restless legs syndrome
  • Pregnancy or suspected pregnancy
  • Participation in another concurrent interventional clinical trial
  • Any unstable medical condition
  • Inability to provide informed consent
  • Inability to adhere to the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then Vertex
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.
Device: iTBS rTMS
Repetitive transcranial magnetic stimulation (rTMS) intermittent Theta Burst Stimulation (iTBS)
Experimental: iTBS rTMS Lateral Parietal Cortex (LPC) then Vertex
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.
Device: iTBS rTMS
Repetitive transcranial magnetic stimulation (rTMS) intermittent Theta Burst Stimulation (iTBS)
Experimental: iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC)
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.
Device: iTBS rTMS
Repetitive transcranial magnetic stimulation (rTMS) intermittent Theta Burst Stimulation (iTBS)
Experimental: iTBS rTMS Vertex then Lateral Parietal Cortex (LPC)
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.
Device: iTBS rTMS
Repetitive transcranial magnetic stimulation (rTMS) intermittent Theta Burst Stimulation (iTBS)
Sham Comparator: iTBS rTMS Vertex only
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.
Device: iTBS rTMS
Repetitive transcranial magnetic stimulation (rTMS) intermittent Theta Burst Stimulation (iTBS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Referrals
Time Frame: 16 weeks
Total number of participants referred to the study by clinicians
16 weeks
Participant enrollment
Time Frame: 16 weeks
Total number of participants enrolled in the study
16 weeks
Treatment adherence
Time Frame: 16 weeks
Total number of participants to comply with all study procedures as identified in the protocol
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria I. Lapid, M.D.

Investigators

  • Principal Investigator: Maria I Lapid, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-010661

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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