Mild Cognitive ImpairmentPUSH-PilotNCT04503096

Plasticity Using Stimulation and Habit: A Pilot Open-label rTMS Study for MCI

A study testing High-dose accelerated rTMS in people with Mild Cognitive Impairment, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 to 85 years
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: High-dose accelerated rTMS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 12 Apr 2021to 27 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 85 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

Age 60-85
English as a first/primary language
Has been diagnosed with MCI by a healthcare provider within the past two years per National Institute on Aging - Alzheimer's Association (NIA-AA) criteria: (1) Concern regarding cognitive decline reported by patient, informant, or clinician, (2) Objective evidence of impairment for age in 1+ cognitive domains, typically memory, (3) Preserved independent function, (4) no dementia.
Has met actuarial neuropsychological criteria for amnestic MCI: (1) ≥2 impaired scores (i.e. ≤16th %ile) within one cognitive domain, or (2) ≥1 impaired scores (i.e. ≤16th %ile) in ≥3 cognitive domains, using demographically-corrected normative data. (1) and (2) must include the Memory domain.
The primary suspected etiology of amnestic MCI must be neurodegenerative, with competing differential diagnoses (e.g. psychiatric disorder, movement disorder, reversible causes, substance use) ruled out as the primary etiology/ies following a clinical evaluation by a healthcare provider.
Ability to provide independent informed consent, consistent with the MCI diagnostic criterion of preserved independent function.

Who cannot join

Dementia diagnosis per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or NIA-AA criteria.
Daily/weekly use of anticholinergics, neuroleptics, sedatives, or bupropion. Stimulant use may be allowed pending investigator review. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen of four weeks prior to enrollment.
History of significant or unstable condition/s that may impact cognition such as significant cardiac, cerebrovascular, or metabolic disease, severe mental illness (e.g. bipolar disorder, psychoses), alcohol or substance use disorder, developmental disorder, or other neurologic disease (e.g. severe brain injury, seizures).
MRI and TMS contraindications (e.g., implants, claustrophobia, conditions/treatments that lower seizure threshold, taking medications that have short half-lives, no quantifiable motor threshold, active substance use disorder, bipolar disorder).
Is enrolled in a clinical trial and/or has received an investigational medication within the last 30 days.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: High-dose Accelerated Repetitive Transcranial Magnetic Stimulation to Cognitive Control Neurocircuitry in Mild Cognitive Impairment: A Safety and Feasibility Study

The goal of this pilot study is to determine whether a high-dose form of non-invasive brain stimulation is a promising and safe treatment for Mild Cognitive Impairment (MCI). Transcranial magnetic stimulation (TMS) is an FDA approved treatment for depression. In studies of TMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, the current study is testing whether TMS is safe, feasible and effective in improving cognition in individuals with MCI.

Conditions: Mild Cognitive Impairment
Being tested: High-dose accelerated rTMS
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High-dose accelerated rTMSDevice
A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% resting motor threshold (rMT), intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort.

Study groups in NCT04503096
Study group	Role	What they receive
High-dose accelerated rTMS	Experimental	Not described Receives: Device: High-dose accelerated rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinically Significant Structural Brain Change on T1- and T2-weighted Magnetic Resonance Imaging (MRI)
Clinically significant structural brain change were determined by a board-certified neuroradiologist who reviewed both the pre-treatment and post-treatment structural (T1- and T2-weighted) MRI scans to identify the presence of any changes from pre- to post-treatment based on their clinical read of the images.
Measured: Baseline prior to treatment and at follow-up within 1 week post-treatment
Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
The MoCA is a psychometrist-administered brief cognitive assessment tool with raw total scores ranging from 0 to 30, with higher values indicating better cognition. For this analysis raw total scores were converted to age- and education-adjusted Z-scores using published norms (Rossetti et al., 2011). Z-scores have a mean of 0 and a standard deviation of 1. Lower scores indicate worse performance. The outcome measure reported below is the mean Z-score score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline.
Measured: Baseline prior to treatment and at follow-up within 1 week post-treatment
Change in the Review of Systems Criteria Compared to Baseline
A review of systems questionnaire will be administered to rate the subjective symptom (headache, scalp pain, arm/hand pain, other pain(s), numbness/tingling, other sensation(s), weakness, loss of dexterity, vision/hearing change(s), ear ringing, nausea/vomiting, appetite loss, rash, skin change(s) or any other symptom(s)) on a scale of 0 to 5 (none, minimal, mild, moderate, marked, severe).
Measured: Baseline prior to treatment and at follow-up within 1 week post-treatment
Patient Perception of Treatment Acceptability
A 15-item study-specific questionnaire of rTMS treatment acceptability, with each item rated on a scale from 1 to 5 (1 = not at all, 3 = somewhat, 5 = very much so). Higher scores indicate better acceptability for the first 10 items, lower scores indicate better acceptability for the last 5 items.
Measured: Administered at post-treatment
Retention Rate
Percentage of participants who completed the study (n=21) relative to all participants who initiated treatment (n=22).
Measured: Baseline prior to treatment and at follow-up within 1 week post-treatment

Secondary outcomes (3)

Change From Baseline Depression, as Measured by the Hamilton Depression Rating Scale (HAM-D)
The Hamilton Depression Rating Scale (Ham-D) is a 17-item interviewer-administered structured questionnaire designed to assess symptoms of depression with scores ranging from 0 to 53, with higher scores indicating more depressive symptoms. The outcome measure reported below is the mean score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline.
Measured: Baseline prior to treatment and at follow-up within 1 week post-treatment
Change From Baseline Depression, as Measured by the Geriatric Depression Scale (GDS)
The Geriatric Depression Scale (GDS) is a 30-item scale that evaluates the severity of depressive symptoms in older adults with scores ranging from 0 to 30, with higher scores indicating more depressive symptoms. The outcome measure reported below is the mean score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline.
Measured: Baseline prior to treatment and at follow-up within 1 week post-treatment
Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery
Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 4 NIHTB-CB tests: the flanker inhibitory control, list sorting working memory, pattern comparison processing speed, and dimensional change card sort tests. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance. The outcome measure reported below is the mean T-score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline.
Measured: Baseline prior to treatment and at follow-up within 1 week post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 202127 Jul 2022

First posted7 Aug 2020
Study start12 Apr 2021
Primary completion29 Jun 2022
Study completion27 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04503096
Sponsor's protocol ID: Pro00100536
Acronym: PUSH-Pilot
Status last verified: Sep 2023
First submitted: 3 Aug 2020
Last updated: 7 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Aghamoosa S, Lopez J, Rbeiz K, Fleischmann HH, Horn O, Madden K, Caulfield KA, Antonucci MU, Revuelta G, McTeague LM, Benitez A. A phase I trial of accelerated intermittent theta burst rTMS for amnestic MCI. J Neurol Neurosurg Psychiatry. 2024 Oct 16;95(11):1036-1045. doi: 10.1136/jnnp-2023-332680.
PubMed 38719432

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: High-dose Accelerated Repetitive Transcranial Magnetic Stimulation to Cognitive Control Neurocircuitry in Mild Cognitive Impairment: A Safety and Feasibility Study
ClinicalTrials.gov ID: NCT04503096
Acronym / sponsor ID: PUSH-Pilot / Pro00100536
Conditions: Mild Cognitive Impairment
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Center of Neuromodulation for Rehabilitation
Study start: 12 Apr 2021 (actual)
Primary completion: 29 Jun 2022 (actual)
Study completion: 27 Jul 2022 (actual)
First posted: 7 Aug 2020 (actual)
Results: Posted 19 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
High-dose accelerated rTMS	Experimental	Device: High-dose accelerated rTMS

Who may qualify

Ages: 65 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

Age 60-85
English as a first/primary language
Has been diagnosed with MCI by a healthcare provider within the past two years per National Institute on Aging - Alzheimer's Association (NIA-AA) criteria: (1) Concern regarding cognitive decline reported by patient, informant, or clinician, (2) Objective evidence of impairment for age in 1+ cognitive domains, typically memory, (3) Preserved independent function, (4) no dementia.
Has met actuarial neuropsychological criteria for amnestic MCI: (1) ≥2 impaired scores (i.e. ≤16th %ile) within one cognitive domain, or (2) ≥1 impaired scores (i.e. ≤16th %ile) in ≥3 cognitive domains, using demographically-corrected normative data. (1) and (2) must include the Memory domain.
The primary suspected etiology of amnestic MCI must be neurodegenerative, with competing differential diagnoses (e.g. psychiatric disorder, movement disorder, reversible causes, substance use) ruled out as the primary etiology/ies following a clinical evaluation by a healthcare provider.

Key exclusion criteria (5 listed)

Dementia diagnosis per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or NIA-AA criteria.
Daily/weekly use of anticholinergics, neuroleptics, sedatives, or bupropion. Stimulant use may be allowed pending investigator review. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen of four weeks prior to enrollment.
History of significant or unstable condition/s that may impact cognition such as significant cardiac, cerebrovascular, or metabolic disease, severe mental illness (e.g. bipolar disorder, psychoses), alcohol or substance use disorder, developmental disorder, or other neurologic disease (e.g. severe brain injury, seizures).
MRI and TMS contraindications (e.g., implants, claustrophobia, conditions/treatments that lower seizure threshold, taking medications that have short half-lives, no quantifiable motor threshold, active substance use disorder, bipolar disorder).
Is enrolled in a clinical trial and/or has received an investigational medication within the last 30 days.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High-dose accelerated rTMSA MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% resting motor threshold (rMT), intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort.	Device	High-dose accelerated rTMS

Primary outcome

Number of Participants With Clinically Significant Structural Brain Change on T1- and T2-weighted Magnetic Resonance Imaging (MRI)
Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment
Clinically significant structural brain change were determined by a board-certified neuroradiologist who reviewed both the pre-treatment and post-treatment structural (T1- and T2-weighted) MRI scans to identify the presence of any changes from pre- to post-treatment based on their clinical read of the images.
Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment
The MoCA is a psychometrist-administered brief cognitive assessment tool with raw total scores ranging from 0 to 30, with higher values indicating better cognition. For this analysis raw total scores were converted to age- and education-adjusted Z-scores using published norms (Rossetti et al., 2011). Z-scores have a mean of 0 and a standard deviation of 1. Lower scores indicate worse performance. The outcome measure reported below is the mean Z-score score at the 1-week post-treatment assessment. The statistical analysis compares this mean score to the mean score at Baseline.
Change in the Review of Systems Criteria Compared to Baseline
Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment
A review of systems questionnaire will be administered to rate the subjective symptom (headache, scalp pain, arm/hand pain, other pain(s), numbness/tingling, other sensation(s), weakness, loss of dexterity, vision/hearing change(s), ear ringing, nausea/vomiting, appetite loss, rash, skin change(s) or any other symptom(s)) on a scale of 0 to 5 (none, minimal, mild, moderate, marked, severe).
Patient Perception of Treatment Acceptability
Time frame: Administered at post-treatment
A 15-item study-specific questionnaire of rTMS treatment acceptability, with each item rated on a scale from 1 to 5 (1 = not at all, 3 = somewhat, 5 = very much so). Higher scores indicate better acceptability for the first 10 items, lower scores indicate better acceptability for the last 5 items.
Retention Rate
Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment
Percentage of participants who completed the study (n=21) relative to all participants who initiated treatment (n=22).

3 secondary outcomes

Change From Baseline Depression, as Measured by the Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment
Change From Baseline Depression, as Measured by the Geriatric Depression Scale (GDS)
Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment
Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery
Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment

Results and safety

Results posted to the registry on 19 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-dose Accelerated rTMS	24	21

Primary outcome: Number of Participants With Clinically Significant Structural Brain Change on T1- and T2-weighted Magnetic Resonance Imaging (MRI)

Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment. Count of participants. Unit: Participants

Measure	High-dose Accelerated rTMS n = 21
Value	0

Population analysed: Participants who completed both the pre- and post-treatment assessments were included in this analysis.

Primary outcome: Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)

Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment. Mean (Standard Deviation). Unit: Z-score

Measure	High-dose Accelerated rTMS n = 21
Value	-1.20 (1.18)

High-dose Accelerated rTMS: p = 0.725, t-test, 2 sided

Population analysed: Participants who completed both the pre- and post-treatment assessments were included in this analysis.

Primary outcome: Change in the Review of Systems Criteria Compared to Baseline

Time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment. Count of participants. Unit: Participants

Measure	High-dose Accelerated rTMS n = 21
Headache: Treatment day 1 (Baseline): Minimal/none (0-1)	21
Headache: Treatment day 1 (Baseline): Mild/moderate (2-3)	0
Headache: Treatment day 1 (Baseline): Marked/severe (4-5)	0
Headache: Post-Treatment: Minimal/none (0-1)	20
Headache: Post-Treatment: Mild/moderate (2-3)	1
Headache: Post-Treatment: Marked/severe (4-5)	0
Scalp pain: Treatment day 1 (Baseline): Minimal/none (0-1)	21
Scalp pain: Treatment day 1 (Baseline): Mild/moderate (2-3)	0

Population analysed: Participants who completed both the pre- and post-treatment assessments were included in this analysis.

Primary outcome: Patient Perception of Treatment Acceptability

Time frame: Administered at post-treatment. Median (Inter-Quartile Range). Unit: score on a scale

Measure	High-dose Accelerated rTMS n = 21
"I was motivated to attend the rTMS sessions."	5 (4 to 5)
"I was committed to completing the treatment course."	5 (5 to 5)
"I was interested in the rTMS techniques and learning about them."	5 (5 to 5)
"I understand the purpose of the treatment and how it could help my symptoms."	5 (5 to 5)
"I would be open to completing another course of rTMS treatment in the future, if needed."	5 (5 to 5)
"The rTMS treatment helped improve my ability to cope with daily challenges."	3 (2 to 4)
Paraphrased: Condensed treatment was preferable to conventional treatment course	5 (5 to 5)
"The staff members were attentive and sensitive to my needs during treatment."	5 (5 to 5)

Population analysed: Participants who completed both the pre- and post-treatment assessments were included in this analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-dose Accelerated rTMS	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38719432Aghamoosa S, Lopez J, Rbeiz K, Fleischmann HH, Horn O, Madden K, Caulfield KA, Antonucci MU, Revuelta G, McTeague LM, Benitez A. A phase I trial of accelerated intermittent theta burst rTMS for amnestic MCI. J Neurol Neurosurg Psychiatry. 2024 Oct 16;95(11):1036-1045. doi: 10.1136/jnnp-2023-332680.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andreana Benitez, PhD principal investigator

Medical University of South Carolina

Lisa McTeague, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High-dose accelerated rTMS in people with Mild Cognitive Impairment, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Significant Structural Brain Change on T1- and T2-weighted Magnetic Resonance Imaging (MRI) (time frame: Baseline prior to treatment and at follow-up within 1 week post-treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04503096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.