Trial · NCT04152993
Registered outcomes61
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 61
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Spectral power analysis and oscillatory properties | Baseline | This is associated with Specific Aim 1: To determine electrophysiological biomarkers of fear, extinction and PTSD symptoms. The metric for measurement will be Better Oscillation Detection (BOSC) |
| Primary | Spectral power analysis and oscillatory properties | through study completion, an average of 1 year | This is associated with Specific Aim 1: To determine electrophysiological biomarkers of fear, extinction and PTSD symptoms. The metric for measurement will be Better Oscillation Detection (BOSC) |
| Primary | Cross-frequency coupling and power coherence comodulograms | Baseline | This is associated with Specific Aim 1: To determine electrophysiological biomarkers of fear, extinction and PTSD symptoms. The metric for measurement will be modulation index. |
| Primary | Cross-frequency coupling and power coherence comodulograms | through study completion, an average of 1 year | This is associated with Specific Aim 1: To determine electrophysiological biomarkers of fear, extinction and PTSD symptoms. The metric for measurement will be modulation index. |
| Primary | Region of Interest analysis (FDG PET) | Baseline | This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be Cerebral metabolic rate of glucose (CMRglc) |
| Primary | Region of Interest analysis (FDG PET) | After initial exposure session | This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be Cerebral metabolic rate of glucose (CMRglc) |
| Primary | Region of Interest analysis (FDG PET) | 12 months post-operatively | This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be Cerebral metabolic rate of glucose (CMRglc) |
| Primary | Alpha rhythm frequency (EEG) | Baseline | This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be frequency (Hertz) |
| Primary | Alpha rhythm frequency (EEG) | monthly after implantation for the first year | This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be frequency (Hertz) |
| Primary | Alpha rhythm frequency (EEG) | quarterly during year 2-4 | This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be frequency (Hertz) |
| Primary | Source localization (EEG) | Baseline | This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be discrete dipole fitting. |
| Primary | Source localization (EEG) | through study completion, an average of 1 year | This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be discrete dipole fitting. |
| Secondary | Clinician Administered PTSD Scale | Baseline | This is associated with Specific Aim 3: To assess the efficacy and safety of BLA stimulation for treatment-resistant PTSD. This test will be measured by the score. |
| Secondary | Clinician Administered PTSD Scale | monthly after implantation for the first year | This is associated with Specific Aim 3: To assess the efficacy and safety of BLA stimulation for treatment-resistant PTSD. This test will be measured by the score. |
| Secondary | Occurrence of adverse events | through study completion, an average of 1 year | This is associated with Specific Aim 3: To assess the efficacy and safety of BLA stimulation for treatment-resistant PTSD. This test will be measured by frequency/severity. |
| Secondary | Psychological scales (HAMA) | Baseline | This is associated with Specific Aim 3: To assess the efficacy and safety of BLA stimulation for treatment-resistant PTSD. This test will be measured by the score |
| Secondary | Psychological scales (HAMA) | monthly after implantation for the first year | This is associated with Specific Aim 3: To assess the efficacy and safety of BLA stimulation for treatment-resistant PTSD. This test will be measured by the score |
| Secondary | Psychological scales (HAMA) | every three months up to 48 months after baseline | This is associated with Specific Aim 3: To assess the efficacy and safety of BLA stimulation for treatment-resistant PTSD. This test will be measured by the score |
| Secondary | Psychological scales (MADRS) | Baseline | This is associated with Specific Aim 3: To assess the efficacy and safety of BLA stimulation for treatment-resistant PTSD. This test will be measured by the score |
| Secondary | Psychological scales (MADRS) | monthly after implantation for the first year | This is associated with Specific Aim 3: To assess the efficacy and safety of BLA stimulation for treatment-resistant PTSD. This test will be measured by the score |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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