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New treatment option for Post-Traumatic Stress Disorder
Official title Responsive Neurostimulation for Post-Traumatic Stress Disorder
ClinicalTrials.gov ID: NCT04152993
What this study is testing
- What it's testing
- Post-traumatic stress disorder (PTSD) refractory to treatment is marked by failure of fear extinction and its biological substrate, amygdala reactivity to trauma reminders. Decades of research have clarified the neuronal mechanisms coordinating fear extinction and consolidation.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 60, men only
You may be able to join if
- Male aged 25-60 years.
- Able to give informed consent in accordance with institutional policies and participate in the 4-year follow-up, involving assessments and stimulator...
- Patients must be stable on their current psychotropic medication for a period of 2 months before implantation and agree to not increase dosages or...
- Chart diagnosis of chronic and treatment-refractory PTSD as the principal psychiatric diagnosis and cause of distress and social/occupational...
- Confirmation of PTSD as the primary psychiatric diagnosis by the study psychiatrist via clinical interview and CAPS.
You likely can't join if
- Suicide attempt in the last 2 years and/or presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI...
- Unstable psychosis or bipolar disorder; significant acute or ongoing risk for violence;
- Patients primarily diagnosed with DSM-IV-TR Axis I disorder other than PTSD as determined by the MINI;
- Within the 3 months prior to enrolment, subject has started a new psychotherapy program;
- Alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance...
- Current significant neurological conditions, including epilepsy, stroke, movement disorder; history of serious head injury with loss of consciousness...
See the full eligibility criteria
Who can join
- Male aged 25-60 years.
- Able to give informed consent in accordance with institutional policies and participate in the 4-year follow-up, involving assessments and stimulator adjustments.
- Patients must be stable on their current psychotropic medication for a period of 2 months before implantation and agree to not increase dosages or add any new medications for the first 6 months of the study, unless...
- Chart diagnosis of chronic and treatment-refractory PTSD as the principal psychiatric diagnosis and cause of distress and social/occupational impairment.
- Confirmation of PTSD as the primary psychiatric diagnosis by the study psychiatrist via clinical interview and CAPS.
- Minimum 5-year total illness duration, with no 6-month period of clinical remission during the 2 years prior to entry in the study.
- Stage 2 level of treatment resistance as per Sippel et al.136: Clinical record documented failure to respond to adequate (minimum 3 month, with adherence) trials of at least 3 of the following evidence-based treatments...
- Patients who are unable to complete trauma-focused psychotherapy may be included if they began treatment, and the cause of treatment cessation was that the risks of further treatment, including intense psychological...
- All evidence-based psychotherapy for PTSD has been completed a minimum of 3 months prior to enrolment.
- Minimum baseline past month CAPS-5 Score of 47, with full PTSD diagnostic criteria met, and scores of ≥ 3 on at least one item from the intrusive (CAPS-5 items 1-5) and hyperarousal (CAPS-5 Items 15-20) clusters; and...
- Clinically significant impairment in occupational functioning due to PTSD, manifested by one or more of the following: a) Total federal (service connected ≥ 70%), or State (SSI) disability compensation for at least the...
- Presence in the veteran's life of a spouse, family member or friend who can confirm the symptoms and impairment from PTSD and lack of symptomatic remission in the past 2 years; participate with the study psychiatrist in...
- Willingness to have unexpected neurological or psychiatric symptom shared with the study psychiatrists and other study clinicians.
- Other medical conditions must be stable for at least 1 year, (conditions that require intermittent use of steroids or chemotherapy are excluded).
What rules you out
- Suicide attempt in the last 2 years and/or presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview);
- Unstable psychosis or bipolar disorder; significant acute or ongoing risk for violence;
- Patients primarily diagnosed with DSM-IV-TR Axis I disorder other than PTSD as determined by the MINI;
- Within the 3 months prior to enrolment, subject has started a new psychotherapy program;
- Alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response;
- Current significant neurological conditions, including epilepsy, stroke, movement disorder; history of serious head injury with loss of consciousness if associated with neurological or neuropsychological deficit that...
- Uncontrolled medical condition including cardiovascular problems and diabetes;
- Uncontrolled chronic pain;
- Baseline Montgomery Asberg Depression Rating Scale (MADRS) of ≥ 28;
- Use of warfarin;
- Significant abnormality on preoperative structural brain MRI;
- ECT in the past 6 months;
- Contraindications to MRIs or the need for recurrent body MRIs;
- Immunosuppression;
- High risk for surgery;
- Current pursuit of new or increased disability compensation for PTSD;
- Intracranial implants (aneurysm clip, shunt, cochlear implant, electrodes);
- Patient has had past cranial neurosurgery;
- Use of other investigational drugs within 30 days of baseline.
- Patients suffering from a neurovascular condition or other intracranial process.
- Patients suffering from a condition associated with a significant cognitive impairment.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 25 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.