At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Label Study of the Efficacy, Durability, Safety and Feasibility of Intermittent Theta Burst Stimulation (iTBS) in Adolescents With Major Depressive Disorder: Effect Duration, Suicidality, and Non-Suicidal Self Injurious Behavior
In Brief
A clinical study evaluating iTBS Device/Motor Threshold Coil and iTBS Device/Treatment Coil for Depression. Completed, enrolled 5 participants across 1 site.
Detailed Summary
This is an open label, pilot, feasibility study evaluating effects of Intermittent Theta Burst Transcranial Magnetic Stimulation (iTBS) on 5 eligible adolescents for the treatment of depression. Safety and tolerability will be evaluated with changes in depression scores, and suicidality and non-suicidal self injurious behavior will also be monitored for exploratory and safety measures.
Study Details
Timeline
Interventions
Motor Threshold determination, done prior to starting treatments, determines the location and the intensity for the iTBS treatments. A magnetic field is applied with increasing intensity stimulating the motor region of the brain until there is thumb movement; this indicates the intensity of the treatments; the location for treatment is in the sensory area parallel to this location.
iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes, and sessions are provided 20 times (Monday-Friday for 4 consecutive weeks).