Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD

Part of paid clinical trials in East Providence, Rhode Island.

Sponsor
Bradley Hospital
Study ID
NCT07219810
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • intermittent theta burst stimulation (iTBS) — DEVICE
    Device: Stimulation will be delivered using a Nexstim NBT System 2 device. Motor Threshold: The iTBS pulse intensity will be set at 80% of resting motor threshold (MT). The iTBS protocol will administer 2-second trains with an 8-second inter-burst interval for 1800 pulses \[600 bursts\]), in 50 Hz bursts at 5 Hz (i.e., 200 ms intervals). Each session will last approximately nine minutes. As three sessions will be administered per day, there will be a 20-30 minutes break between each of the nine-minute iTBS sessions. Magnetic pulses will be delivered in an MRI neuro-navigated manner using a cooled figure-eight coil. The PreSMA target will be approximately defined based on MNI coordinates: 13, 18, 62. The left DLPFC target will be approximately defined based on MNI coordinates: -44, 28, 16.

Study Details

The objective of this project is to examine the differential therapeutic effect of intermittent theta burst stimulation (iTBS; a type of repetitive transcranial magnetic stimulation) to the left DLPFC versus right PreSMA in modulating working memory (WM) versus inhibitory control (IC) deficits. Fifty adolescents (12-18 years old) with parent-reported WM and IC deficits and diagnosed ADHD will be randomized to DLPFC or PreSMA targeted 3x-daily iTBS for a total of ten days (30 total sessions).

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: iTBS to the left DLPFC
  • Active Comparator: iTBS to the right pre-SMA

Primary Outcome Measure

EEG, source-localized oscillatory beta band bursting during SST/SWMT [ Time Frame: Visit 13, approximately 1-2 days after iTBS ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
E. P. Bradley HospitalEast ProvidenceRhode Island02915
Brian C Kavanaugh; PI, PsyD ABPP
[email protected]
4014321359

Find similar trials in East Providence, RI

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
E. P. Bradley Hospital· East Providence, RI

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