N/A
N=50
Accelerated TMS to a Novel Brain Target in MDD and PTSD
Post Traumatic Stress Disorder · Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03114891 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Percent Change in Depression Severity of TMS at fMRI-guided Brain Target vs Standard Brain Target — 49.11; 24.94; 36.47; 42.56 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (TMS) (Device); Task (Behavioral); fMRI-guided TMS target (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Depression Severity of TMS at fMRI-guided Brain Target vs Standard Brain Target |
49.11; 24.94; 36.47; 42.56 | — |
Summary
This is a Clinical Trial designed to evaluate novel transcranial magnetic stimulation (TMS) methods for treating depression/PTSD. TMS is an FDA-approved procedure for treatment-resistant depression. The use of the stimulation in this current study is considered experimental. The purpose of this research study is to compare the effects of TMS at two different brain regions. This information will help the investigators to determine which treatment strategies provide the greatest clinical benefit to patients. Results of the study will provide brain and behavior measures for future work, which may be critical to developing effective disease markers and novel treatments for psychiatric conditions.
Eligibility Criteria
Inclusion Criteria
- 18-60 years old, male or female, any race
- Patients must currently meet sufficient DSM criteria for PTSD and have symptoms of depression; or meet criteria for trauma-induced MDD
- Capacity to give informed consent and follow study procedures
- English speaking
Exclusion Criteria
- Outside age range
- Patient does not meet sufficient DSM criteria for PTSD or MDD
- Psychiatric medication use
- Significant handicaps (e.g. mental handicap) that would interfere with testing procedures
- MRI contraindications
- Additional TMS contraindications
- Medication use that substantially reduces seizure threshold to TMS (olanzapine, chlorpromazine, lithium)
- Opiate medication
- Known neurological disorders including multiple sclerosis, encephalopathy, seizure disorder, brain tumors
- Current alcohol or substance abuse disorder (moderate or severe)
- Current schizophrenia or other psychotic disorder, or current bipolar disorder
- Refusal to abstain from illicit drug use for the duration of the study
- Refusal to abstain from alcohol within 24 hours of the MRI scan
- Pregnancy
- Newly initiated psychotherapy (less than 6 weeks)
Data sourced from ClinicalTrials.gov (NCT03114891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.