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Procedure

Accelerated iTBS for Mild Cognitive Impairment (PUSH2 Trial)

N/A

Recruiting

Led By Lisa McTeague

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 (1 week pre-treatment), week 3 (1 week post-treatment), week 10 (8 weeks post-treatment), and week 26 (6 months post-treatment)

Summary

This trial is studying if a non-invasive brain stimulation technique can improve depression & cognitive function in people with Mild Cognitive Impairment. It hopes to find the right dose to inform future clinical trials. Goal is to prevent dementia.

Who is the study for?

This trial is for people aged 60-85 with mild cognitive impairment (MCI) and moderate to severe depression. Participants must have a stable medication regimen, adequate mental and motor functions, an informant who knows them well, and meet specific neuropsychological criteria for MCI.

What is being tested?

The study tests accelerated Transcranial Magnetic Stimulation (TMS), comparing it to a sham procedure to see if it can improve depression and cognitive function in MCI patients. The right TMS dose needs identification before larger trials on its effectiveness.

What are the potential side effects?

While the document doesn't list side effects specifically, common ones from TMS may include headaches, scalp discomfort at the stimulation site, tingling or spasms of facial muscles, lightheadedness, or seizures (rare).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 (1 week pre-treatment), week 3 (1 week post-treatment), week 10 (8 weeks post-treatment), and week 26 (6 months post-treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 (1 week pre-treatment), week 3 (1 week post-treatment), week 10 (8 weeks post-treatment), and week 26 (6 months post-treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (1 week pre-treatment), week 3 (1 week post-treatment), week 10 (8 weeks post-treatment), and week 26 (6 months post-treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Geriatric Depression Scale (GDS) raw score

Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite

Secondary study objectives

Change in Alzheimer's Disease Cooperative Study scale for Activities of Daily Living in MCI (ADCS-ADL-MCI)

Change in Clinical Dementia Rating (CDR) scale Sum of Boxes

Change in PROMIS Depression T-score

Other study objectives

Change in Dimensional Apathy Scale (DAS) raw scores

Change in NIH Toolbox-Emotion Battery (NIHTB-EB) T-scores

Change in Network Functional Connectivity

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose Step 6 - 60 Active Accelerated iTBS SessionsExperimental Treatment1 Intervention

Participant will receive 10/10 active sessions and 0/10 sham sessions per day for a total of 60 active sessions (36,000 active pulses).

Group II: Dose Step 5 - 48 Active Accelerated iTBS SessionsExperimental Treatment2 Interventions

Participant will receive 8/10 active sessions and 2/10 sham sessions per day for a total of 48 active sessions (28,800 active pulses).

Group III: Dose Step 4 - 36 Active Accelerated iTBS SessionsExperimental Treatment2 Interventions

Participant will receive 6/10 active sessions and 4/10 sham sessions per day for a total of 36 active sessions (21,600 active pulses).

Group IV: Dose Step 3 - 24 Active Accelerated iTBS SessionsExperimental Treatment2 Interventions

Participant will receive 4/10 active sessions and 6/10 sham sessions per day for a total of 24 active sessions (14,400 active pulses).

Group V: Dose Step 2 - 12 Active Accelerated iTBS SessionsExperimental Treatment2 Interventions

Participant will receive 10 sessions of accelerated iTBS on each of 6 treatment days, including 2/10 active sessions and 8/10 sham sessions per day for a total of 12 active sessions (7,200 active pulses).

Group VI: Dose Step 1 - 0 Active Accelerated iTBS SessionsPlacebo Group1 Intervention

Participant will receive 10 sessions of accelerated iTBS on each of 6 treatment days, including 0/10 active sessions and 10/10 sham sessions per day for a total of 0 active sessions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sham Comparator

1997

Completed Phase 3

~2950

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