Your session is about to expire
← Back to Search
Procedure
Accelerated iTBS for Mild Cognitive Impairment (PUSH2 Trial)
N/A
Recruiting
Led By Andreana Benitez, PhD
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)
Awards & highlights
PUSH2 Trial 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.Check my eligibility
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.See study design
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).
PUSH2 Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Geriatric Depression Scale (GDS) raw score
Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite
Secondary outcome measures
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 outcome measures
Change in Dimensional Apathy Scale (DAS) raw scores
Change in NIH Toolbox-Emotion Battery (NIHTB-EB; Negative Affect, Social Satisfaction, Psychological Well-being) T-scores
Change in Network Functional Connectivity
+1 morePUSH2 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
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,576 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,825 Total Patients Enrolled
Andreana Benitez, PhDPrincipal InvestigatorMedical University of South Carolina
2 Previous Clinical Trials
73 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with dementia or a major thinking (cognitive) disorder.I've been on a stable dose of certain medications like antidepressants for over 4 weeks.I have a condition or have received treatment that could affect my thinking.I can move, feel, and speak well enough to complete tests.I have been diagnosed with moderate to severe depression.I have been treated with monoclonal antibody therapy for Alzheimer's or mild cognitive impairment.I am between 60 and 85 years old.I have been on the same medication for at least 4 weeks.I was diagnosed with mild cognitive impairment due to Alzheimer's or small vessel disease within the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Step 5 - 48 Active Accelerated iTBS Sessions
- Group 2: Dose Step 6 - 60 Active Accelerated iTBS Sessions
- Group 3: Dose Step 1 - 0 Active Accelerated iTBS Sessions
- Group 4: Dose Step 2 - 12 Active Accelerated iTBS Sessions
- Group 5: Dose Step 3 - 24 Active Accelerated iTBS Sessions
- Group 6: Dose Step 4 - 36 Active Accelerated iTBS Sessions
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any eligibility criteria to join this research project?
"To qualify for this research, individuals should possess a diagnosis of mild cognitive impairment and meet the age requirement (between 60-85 years old). Currently, there is need for 60 participants."
Answered by AI
Is the criteria for this investigation limited to individuals aged 35 or younger?
"In order to meet the requirements of this trial, participants should not exceed 85 years old and must have reached 60 years in age."
Answered by AI
Are any individuals being accepted to participate in this experiment currently?
"As detailed on clinicaltrials.gov, this trial is not currently recruiting patients. Initially posted in September 15th 2023 and edited lastly on August 7th of the same year, it does not appear that enrolment has begun yet; however there are a total 1808 other studies looking for participants at present."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger