N/A
N=33
Brain Imaging of rTMS Treatment for Depression
Major Depressive Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT01829165 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Clinician Administered HAM-D — 27.0; 26.2; 22.0; 22.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTMS Treatment (Device); Sham rTMS Treatment (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered HAM-D |
27.0; 26.2; 22.0; 22.7; 17.9; 17.6 | — |
Summary
The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the investigators can overcome a major limitation of neuroimaging - the inability to demonstrate causality. The investigators' findings will serve as a platform for future studies wherein TMS treatment can be directly guided by the investigators' ability to image and causally manipulate specific neural networks.
Aim 1: To examine causal interactions between two major brain networks in depression.
Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in depression.
Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls, in two targeted and interacting networks, using concurrent transcranial magnetic stimulation (TMS) and functional magnetic resonance imaging (fMRI).
Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in normalization of baseline network-level deficits, and be predicted by degree of baseline network abnormalities.
Eligibility Criteria
Inclusion Criteria
- Men and women, ages 18 to 50
- Depression assessed through phone screen
- Must comprehend English well to ensure adequate comprehension of the fMRI and TMS instructions, and of clinical scales
- Has failed >1 previous adequate antidepressant medication trials
- Right-handed
- No current or history of neurological disorders
- No seizure disorder or risk of seizures
Exclusion Criteria
- Any contraindication to being scanned in the 3T scanners at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at the Lucas Center or CNI
- Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
- Current rTMS treatment or prior treatment failure with rTMS
- Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
- Currently pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01829165). 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.