NCT05327257

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

March 20, 2022

Last Update Submit

January 9, 2026

Conditions

Mild Cognitive Impairment

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

  • Clinician Referrals

    Total number of participants referred to the study by clinicians

    16 weeks

  • Participant enrollment

    Total number of participants enrolled in the study

    16 weeks

  • Treatment adherence

    Total number of participants to comply with all study procedures as identified in the protocol

    16 weeks

Study Arms (5)

iTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then Vertex

EXPERIMENTAL

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

iTBS rTMS Lateral Parietal Cortex (LPC) then Vertex

EXPERIMENTAL

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

iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC)

EXPERIMENTAL

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

iTBS rTMS Vertex then Lateral Parietal Cortex (LPC)

EXPERIMENTAL

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

iTBS rTMS Vertex only

SHAM COMPARATOR

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

Interventions

iTBS rTMSDEVICE

Repetitive transcranial magnetic stimulation (rTMS) intermittent Theta Burst Stimulation (iTBS)

iTBS rTMS Lateral Parietal Cortex (LPC) then VertexiTBS rTMS Left Dorsolateral Prefrontal Cortex (DLPFC) then VertexiTBS rTMS Vertex onlyiTBS rTMS Vertex then Lateral Parietal Cortex (LPC)iTBS rTMS Vertex then Left Dorsolateral Prefrontal Cortex (DLPFC)

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Lapid MI, Pagali SR, Basso MR, Croarkin PE, Geske JR, Huston J 3rd, Islam K, Joseph B, Kennebeck WW, Kang D, Kung S, LeMahieu AM, Lundstrom BN, Petersen RC, Sarran MM, Shu Y, Swanson IM, St Louis EK, Wang MK, Varatharajah Y, Wagh N, Welker KM, Worrell GA, Boeve BF. A 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): a study protocol. Pilot Feasibility Stud. 2025 Apr 1;11(1):35. doi: 10.1186/s40814-025-01625-5.

    PMID: 40170189DERIVED

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Maria I Lapid

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participant, care provider, investigator and outcomes assessor blinded to treatment arm
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2022

First Posted

April 14, 2022

Study Start

August 11, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)