iTBS for Adolescent Depression: An Open Label Study Evaluating Safety and Efficacy of Treatment
NCT ID: NCT04485455
Last Updated: 2021-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2020-09-21
2021-07-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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iTBS Therapy
Teenage participants with depression will receive iTBS therapy using a Transcranial Magnetic Stimulation (TMS) protocol delivering electro-magnetic stimulation
iTBS Device/Motor Threshold Coil
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 Device/Treatment Coil
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).
Interventions
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iTBS Device/Motor Threshold Coil
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 Device/Treatment Coil
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documentation of DSM-V criteria for current MDD or TRD will be required for study entry.
* Patients may be on antidepressant medication at a stable dose or receiving psychotherapy with a licensed provider during the active phase of TMS treatment for 4 weeks.
* Ability to provide consent and take part in questionnaires and scales (i.e.: not currently intellectually disabled).
* The presence of suicidality or NSSIB are not required to enter this study. Although our secondary end-points include suicidality, and the investigators are also exploring NSSIB, and thus this may not lead to many data, the investigators' plan is to use data from this study to justify a larger study where this can be more robustly investigated.
Exclusion Criteria
* Presence of intracranial metallic implants or fragments, which is a contraindication for TMS.
* Lifetime history of (or currently present) epilepsy.
* Current diagnosis of substance abuse, eating disorder, PTSD (Post Traumatic Stress Disorder), or intellectual disability.\* Nicotine use disorder will not directly preclude a potential subject from this study. Although chronic nicotine use does effect central nervous system excitability, what would be more confounding to our study would be if there is a sudden change in nicotine use during the treatment phase, as this may affect the motor threshold. Inclusion will however be at the PI's discretion.
* Current imminent suicide ideation or other clinical reasons for inpatient psychiatric hospitalization.
* Currently pregnant. There is currently not adequate data from this population to ensure safety with the scope of this protocol.
* Any reason the investigator determines may cause noncompliance with study rules or is unfit for receiving treatment.
* Currently taking certain medications including antidepressants, stimulants, benzodiazepines, and antipsychotics, antiepileptic (per investigator discretion).
* Any positive drug testing from a urine drug test unless medically indicated with a valid prescription.
* Those with marijuana/cannabis positive results may retest later if at that time they do not meet criteria for substance abuse at screening and agree to refrain from use for the duration of study participation. Decision to be made by Investigator discretion.
13 Years
17 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Shahzad Ali, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill-Psychiatry Outpatient Clinic
Chapel Hill, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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19-1100
Identifier Type: -
Identifier Source: org_study_id