Modulation of Frontoparietal Dynamics Underlying Adolescent Working Memory Deficits

NCT05119660 | Unknown DMC FDA Device

• 1 other identifier: BradleyH002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether a single session of brain stimulation (called repetitive transcranial magnetic stimulation \[rTMS\]) can improve the brain activity underlying 'working memory.' Working memory is the ability to hold information 'in mind' to complete daily activities. This study involves teenagers with ADHD as well as healthy young adults. It is funded by The COBRE Center for Neuromodulation (CCN) at Butler Hospital (Pilot Project)

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• Change in Theta-Gamma Coupling After Sham iTBS

  EEG recording will be obtained while the participant completes the Sternberg Spatial Working Memory Test (SWMT). The coupling between theta phase and gamma amplitude will be extracted from the EEG during encoding and maintaining demands. The change between pre and post a single iTBS session will be calculated.

  Theta-gamma coupling will be obtained before and after iTBS administration. There will be approximately 5 minutes between the pre and post EEG recordings. The change between pre and post is the outcome variable.

• Change in Theta-Gamma Coupling after Active iTBS

  EEG recording will be obtained while the participant completes the Sternberg Spatial Working Memory Test (SWMT). The coupling between theta phase and gamma amplitude will be extracted from the EEG during encoding and maintaining demands. The change between pre and post a single iTBS session will be calculated.

  Theta-gamma coupling will be obtained before and after iTBS administration. There will be approximately 5 minutes between the pre and post EEG recordings. The change between pre and post is the outcome variable.

Study Arms (2)

Patient Arm

EXPERIMENTAL

In a 2x2 factorial double-blind design, we will randomize a sample of adolescents (13-18 years) 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.

Device: Intermittent Theta Burst Stimulation

Healthy Control Arm

EXPERIMENTAL

Control Arm: A sample of healthy young adults (18-25 years) will receive an individualized theta-gamma parameters protocol of iTBS to the left DLPFC. 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.

Device: Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst Stimulation DEVICE

iTBS

Healthy Control Arm; Patient Arm

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ability to provide assent and have parent provide parental permission
• English fluency of the participant and the legal guardian/parent
• years
• Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean.
• IQ \> 80
• Clinical diagnosis of attention deficit hyperactivity disorder (ADHD): predominantly inattentive type, predominantly hyperactive/impulsive type, combined type, or unspecified type. Diagnostic criteria will be confirmed with NICHQ Vanderbilt Assessment Scales-Parent.
• Ability to provide consent
• English fluency of the participant
• years
• Never diagnosed or meets current criteria for a psychiatric disorder, as measured by self-report of prior diagnoses and formal completion of the diagnostic interview.

You may not qualify if:

• Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
• History of fainting spells of unknown or undetermined etiology that might constitute seizures
• History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
• Any progressive (e.g., neurodegenerative) neurological disorder
• Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants, braces or fillings)
• Non-removable makeup or piercings
• Pacemaker
• Implanted medication pump
• Vagal nerve stimulator
• Deep brain stimulator
• TENS unit (unless removed completely for the study)
• Ventriculo-peritoneal shunt
• Signs of increased intracranial pressure
• Intracranial lesion (including incidental finding on MRI)

Sponsors & Collaborators

• Bradley Hospital: lead
• Funding Source: COBRE Center for Neuromodulation at Butler Hospital (Pilot Project): collaborator

Study Sites (1)

E. P. Bradley Hospital

East Providence, Rhode Island, 02915, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Brian C Kavanaugh, PsyD ABPP

CONTACT

401 432 1359; Bkavanaugh@Lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 15, 2021
• Study Start: October 1, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: September 28, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)