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Brain Stimulation
Brain Stimulation for Working Memory Issues
N/A
Recruiting
Research Sponsored by Bradley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up theta-gamma coupling will be obtained immediately before (i.e., pre-itbs) and after itbs (i.e., post-itbs). there will be approximately 5 minutes between the pre and post eeg recordings. the change between pre-itbs and post-itbs is the outcome variable.
Awards & highlights
No Placebo-Only Group
Summary
This trial will use brain scans to see if non-invasive brain stimulation can improve working memory problems in adolescents, and help treat their mental health issues.
Who is the study for?
This trial is for adolescents aged 13-17 with an IQ over 80 and diagnosed ADHD, who struggle with working memory. They must be fluent in English, able to consent (with parental permission), and have a parent-reported BRIEF-2 Working Memory score above the norm. Exclusions include certain neurological conditions, metal implants affecting the brain or spinal cord, active psychosis or mania, current pregnancy, substance abuse within six months, and other specific medical criteria.
What is being tested?
The study tests whether non-invasive brain stimulation called Intermittent Theta Burst Stimulation can improve working memory in teens by targeting prefrontal and parietal brain regions. Participants will receive either the active treatment or a sham (placebo) version to compare effects on neural mechanisms underlying memory deficits.
What are the potential side effects?
While not explicitly listed here, side effects of Theta Burst Stimulation may include mild headaches or discomfort at the stimulation site; however individual experiences may vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ theta-gamma coupling will be obtained immediately before (i.e., pre-itbs) and after itbs (i.e., post-itbs). there will be approximately 5 minutes between the pre and post eeg recordings. the change between pre-itbs and post-itbs is the outcome variable.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~theta-gamma coupling will be obtained immediately before (i.e., pre-itbs) and after itbs (i.e., post-itbs). there will be approximately 5 minutes between the pre and post eeg recordings. the change between pre-itbs and post-itbs is the outcome variable.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Theta-Gamma Coupling After Sham iTBS
Change in Theta-Gamma Coupling after Active iTBS
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sham intermittent Theta Burst StimulationExperimental Treatment1 Intervention
In a 2x2 factorial double-blind design, researchers will randomize a sample of adolescents with WM deficits to intermittent theta burst stimulation (iTBS) at the left dorsolateral prefrontal cortex (DLPFC) or inferior parietal lobule (IPL), based on each participant's structural brain MRI.
Participants in both arms will complete an active iTBS session and a sham iTBS session. The primary outcome will be theta-gamma coupling during WM demands, as measured via electroencephalography (EEG) during a Sternberg spatial WM task (SWMT) immediately before and after iTBS.
Group II: Active intermittent Theta Burst StimulationExperimental Treatment1 Intervention
In a 2x2 factorial double-blind design, researchers will randomize a sample of adolescents with WM deficits to intermittent theta burst stimulation (iTBS) at the left dorsolateral prefrontal cortex (DLPFC) or inferior parietal lobule (IPL), based on each participant's structural brain MRI.
Participants in both arms will complete an active iTBS session and a sham iTBS session. The primary outcome will be theta-gamma coupling during WM demands, as measured via electroencephalography (EEG) during a Sternberg spatial WM task (SWMT) immediately before and after iTBS.
Find a Location
Who is running the clinical trial?
Bradley HospitalLead Sponsor
19 Previous Clinical Trials
1,618 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures or epilepsy, or a close family member does.I am experiencing symptoms of high pressure inside my skull.I have been diagnosed with ADHD.I have had fainting spells that might be seizures.I am between 12-18 years old with ADHD and struggle with working memory.I have major issues with my vision, hearing, or speech.I am on chronic medication that affects seizure risk, excluding psychostimulants.I have a brain condition due to genetics or a past injury or disease.I have a brain lesion found on an MRI.I have a worsening neurological condition.I don't have chronic conditions like heart issues or asthma that could worsen with a seizure.
Research Study Groups:
This trial has the following groups:- Group 1: Sham intermittent Theta Burst Stimulation
- Group 2: Active intermittent Theta Burst Stimulation
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.