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Behavioural Intervention
Brain Stimulation for Mild Cognitive Impairment
N/A
Recruiting
Led By Robin Hilsabeck, PhD, ABPP
Research Sponsored by University of Texas at Austin
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 up to 1 hour after intervention
Awards & highlights
Study Summary
This trial will investigate whether non-invasive brain stimulation can improve cognitive function in older adults with mild cognitive impairment.
Who is the study for?
This trial is for healthy adults aged 18-35 and older adults aged 60-90 with mild cognitive impairment (MCI) who have at least an elementary school education, normal or corrected vision, and good general health. Participants must score at least 23 on the Montreal Cognitive Assessment. Those with EEG/TMS acquisition issues, MRI contraindications, neurological/psychiatric diseases, or using certain psychotropic/cognitive enhancing medications cannot join.Check my eligibility
What is being tested?
The study tests if theta burst stimulation (TBS), a non-invasive brain stimulation technique, can improve cognitive functions in people with MCI. It compares sham (fake) TBS to two types: closed-loop TBS triggered by specific brain signals during a video game task and open-loop TBS that's not contingent on brain activity.See study design
What are the potential side effects?
While the document doesn't specify side effects of TBS directly, common ones may include discomfort at the stimulation site, headache, lightheadedness or seizures; however these are generally rare and will be monitored closely by researchers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 hour after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 hour after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accuracy of the BCI classifier output
Behavioral performance of the video game task
Cognitive assessment I: Montreal Cognitive Assessment
+10 moreTrial Design
3Treatment groups
Active Control
Group I: Closed-Loop TBSActive Control1 Intervention
Group II: Sham TBSActive Control1 Intervention
Group III: Open-Loop TBSActive Control1 Intervention
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,064 Total Patients Enrolled
Robin Hilsabeck, PhD, ABPPPrincipal InvestigatorUniversity of Texas at Austin
José del R. Millán, PhDPrincipal InvestigatorUniversity of Texas at Austin
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60-90 years old with mild memory problems, in good health, and can see well with glasses if needed.I am currently taking medication to improve my memory or attention.I don't have skin issues that would interfere with EEG or TMS procedures.I do not have a history of major neurological or psychiatric conditions.I am 18-35, healthy, with good vision (or corrected) and understand middle school level instructions.I am currently taking medication that affects my thinking or mood.I am between 60-90, healthy, with good vision and at least elementary education. My mental function test score is 23 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Closed-Loop TBS
- Group 2: Sham TBS
- Group 3: Open-Loop TBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is eligibility for this scientific study limited to those under 50 years of age?
"As per the conditions of participation, participants must be 18 years old or older but not exceeding 90."
Answered by AI
What is the enrollment capacity of this medical research project?
"Affirmative. Data hosted on clinicaltrials.gov reveals that this medical research, which was initially posted on May 31st 2023, is actively recruiting and requires 180 patients to be sourced from a single centre."
Answered by AI
Is there still capacity for more participants in this research?
"Affirmative. Per the information posted on clinicaltrials.gov, this medical research is now recruiting participants from one study site. It was initially advertised on May 31st 2023 and has been updated as recently as June 7th 2023 with a goal to recruit 180 patients in total."
Answered by AI
Is there any possibility of me participating in this experiment?
"This clinical trial welcomes applications from individuals with mild cognitive impairment aged between 18 and 90. Approximately 180 patients are expected to be admitted into the study."
Answered by AI
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