rTMS for Mild Cognitive Impairment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Maria I. Lapid, M.D.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Maria I Lapid

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

Ability to provide informed consent

I can see and hear well enough to take psychological tests.

My thinking and memory skills are generally good.

Exclusion Criteria

Substance use disorder (except caffeine and nicotine) within the past 12 months

History of traumatic brain injury

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the vertex or DLPFC or LPC

2 weeks

10 visits (in-person)

Washout

Participants undergo a washout period to eliminate the effects of the first treatment before starting the second treatment period

4 weeks

Treatment Period 2

Participants receive 10 consecutive days of daily single session of iTBS rTMS for 3.5 minutes per day over the DLPFC or LPC or vertex

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• iTBS rTMS

Trial Overview 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.

Participant Groups

Group I: iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC) Experimental Treatment 1 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 Treatment 1 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 Vertex Experimental Treatment 1 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 Vertex Experimental Treatment 1 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 only Placebo Group 1 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.

Who Is Running the Clinical Trial?

Maria I. Lapid, M.D.

Lead Sponsor

Trials

1

Recruited

30+