Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT05985356
Eligibility Criteria:
Inclusion Criteria:
1. Signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, female, or non-gender conforming individuals (i.e. those who do not identify as male or female)
4. All racial and ethnic groups
5. Ages 18 to 70
6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per HAM-D and DIAMOND.
7. Meets criteria for current Hoarding Disorder, per SIHD
8. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
9. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
10. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
11. No contraindications to MRI (passes MRI safety screening questionnaire)
12. Able to commit to the treatment schedule
13. Able to complete assessment procedures in English
14. Intact decision-making capacity and ability to provide voluntary informed consent
Exclusion Criteria:
1. History of other neurological condition including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy
2. Implanted medical devices that are not explicitly recognized as MRI safe, including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed
3. Active manic or psychotic illness per DIAMOND
4. Current substance use disorder per DIAMOND
5. Current active suicidal or spontaneously disclosed homicidal ideation. Active suicidal ideation for this study is defined as a score of 3 or greater on the HAMD-17 and/or 3 or more on the PHQ-9.
6. Pregnant or intending to become pregnant within the study period; breastfeeding
7. Other sensory conditions or illnesses precluding participation in assessments or treatment
8. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy
9. Taking medication that lowers seizure threshold
10. Previous failed treatment with rTMS, iTBS, or ECT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05985356
Study Brief:
Protocol Section:
NCT05985356