A Trial of Two-Week Brain Stimulation for Teenagers With ADHD

Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this clinical trial is to examine whether non-invasive brain stimulation can modulate dysfunctional brain dynamics underlying adolescent ADHD to subsequently improve clinical symptoms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• Ability to provide assent and have parent provide parental permission

• English fluency of the participant and the legal guardian/parent

• 12-18 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.

• Participants are allowed to continue clinical ADHD treatments. However, changes to ADHD treatments cannot be made during the entirety of study participation. Confirming a plan of treatment stability will occur as part of initial inclusion criteria. We will check on treatment stability at the start of each two-week phase with the participant and parent, and document accordingly. Changes to treatment will be reviewed by a physician and may result in study termination.

Locations
United States
Rhode Island
E. P. Bradley Hospital
East Providence
Time Frame
Start Date: 2021-10-01
Completion Date: 2026-10-01
Participants
Target number of participants: 25
Treatments
Active_comparator: Active intermittent Theta Burst Stimulation
Participants will complete 10 daily sessions of active iTBS to the left dorsolateral prefrontal cortex
Sham_comparator: Sham intermittent Theta Burst Stimulation
Participants will complete 10 daily sessions of sham iTBS to the left dorsolateral prefrontal cortex
Sponsors
Leads: Bradley Hospital

This content was sourced from clinicaltrials.gov