AzTrials
AzTrials

Post-Traumatic Stress DisorderEarly Phase 1NCT04152993

Responsive Neurostimulation for Post-Traumatic Stress Disorder

A Early Phase 1 study testing NeuroPace® RNS® System in people with Post-Traumatic Stress Disorder, run by VA Greater Los Angeles Healthcare System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 60 years, men only
Conditions the study is for
Post-Traumatic Stress Disorder
What is being tested?
NeuroPace® RNS® System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
22 Mar 2021to 31 Jul 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to 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 medically necessary.
  • 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.
Show all 14Show fewer
  • 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 including at least one pharmacologic agent below, and at least one trauma-focused individual cognitive-behavior psychotherapy among the following: Pharmacologic: sertraline, paroxetine, fluoxetine or venlafaxine, at maximally tolerated FDA recommended doses. Psychotherapy: Prolonged Exposure Therapy (PE); Cognitive Processing Therapy (CPT); Eye movement Desensitization and Reprocessing (EMDR); or other form of evidence-based cognitive behavior therapy for PTSD
  • 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 suffering, outweighed the potential benefits of continuing the treatment.
  • 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 this severity maintained for at least one month during the baseline period based on two separate measures.
  • 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 past 2 years for PTSD; b) global assessment of functioning score ≤ 45; c) no period of full time gainful employment ≥ 3 months in the past 5 years. Or clinically significant impairment in social functioning due to PTSD, manifested by one or more of the following: (i) little or no social activity outside the household other than as necessary for medical appointments, practical matters such as grocery shopping, or to interact with other veterans; (ii) reliable description by a spouse or significant other, living with the patient, of repeated avoidance/refusal to participate in customary social engagements with friends, family or for recreational activities due to PTSD; (iii) two or more verbal or physical interpersonal altercations within the past year requiring another person's intervention to prevent further escalation, or involving law enforcement.
  • 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 answering questions about symptoms and functioning at scheduled follow-up visits; and report unexpected adverse neurological or psychiatric events to study investigators and, if advised by study investigators, assist the patient in accessing necessary services to address obtain care.
  • 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).

Who cannot join

  • 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 could interfere with study participation or outcome assessment; or if associated with structural MRI abnormality.
Show all 21Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sonja Hiller contact

3107947517

shiller@mednet.ucla.edu

Virginia Janovsky contact

3107947517

virginia.janovsky@va.gov

United States1 site, 1 recruiting

  • VA Greater Los Angeles

    Los Angeles, California, 90073

    Virginia Janovsky, virginia.janovsky@va.gov

    Recruiting

Other trials in United States

About this study

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. Fear cells and extinction cells in the basolateral amygdala (BLA) alter their firing rate based on the nature of the stimulus and the influence from the medial prefrontal cortex (mPFC) and the ventral hippocampus (vHPC). Together, the BLA, mPFC, and the vHPC form an anxiety-processing network where the BLA links stimulus to emotion, the vHPC provides memory context, and the mPFC coordinates extinction or consolidation. Local field potential (LFP) recordings from the BLA have revealed specific signals that correspond to an enhanced fear state. Previous studies have shown that neuromodulation of the BLA can promote extinction in a rodent model and in a treatment-refractory PTSD patient. This action is likely carried by disrupting fear signals within the BLA; however, continuous neurostimulation may also disrupt normal function of the amygdala. The present application proposes to investigate the use of Responsive Neurostimulation (RNS, Neuropace) in six (6) veterans suffering from severe treatment-resistant PTSD. This dual-activity device will allow us to chronically record LFPs from the BLA under specific conditions such as fear conditioning, exposure to trauma reminders, and emotional memory encoding and retrieval. In addition, the neural activity will be captured during real-life symptoms of flashback and nightmares. These recordings will provide the specific electrophysiological biomarkers of hypervigilance and re-experiencing. The device will then be programmed to detect and treat these biomarkers with a pre-determined electrical pulse. The patients will be followed prospectively using psychological scales but also with functional neuroimaging and electroencephalograms. These modalities will be used to determine the extent of circuit engagement as a result of the therapy. By approaching PTSD from a fear processing mechanism perspective, our project will serve as a proof of concept for other circuit-based therapies in psychiatry. This proposal is a multi-departmental effort involving 11 investigators across 7 departments and requires a close collaboration between clinical and basic scientists. As a result, the findings underlying chronic recordings will bridge the basic science results from fear conditioning research to clinical neural processes in PTSD patients.

Being tested
NeuroPace® RNS® System
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeuroPace® RNS® SystemDevice

    In this intervention, patients suffering from PTSD undergo a surgical procedure to implant the responsive neurostimulation device (RNS, NeuroPace). This procedure involves the placement of a depth lead bilaterally in the amygdala and hippocampus following a trans-occipital trajectory. The two leads are then connected to a pulse generator fixated to the skull. RNS is able to detect specific signals from the target and to respond with a programmed electrical stimulation. One month after the implantation of the system, the patients will undergo 3 tasks: a fear conditioning task, the international affective picture system and the subsequent memory recall paradigm. These tasks will yield electrophysiological biomarkers of arousal and re-experiencing. We will then program RNS to detect and respond to those biomarkers. The patients will be followed longitudinally for improvement and evidence of target engagement as seen on cerebral metabolism and global electroencephalography.

Study groups in NCT04152993
Study groupRoleWhat they receive
RNS groupExperimentalThis study consists in only one arm. In this arm, the patients will undergo the placement of the RNS implant and the subsequent RNS programming to optimize the PTSD symptoms.
Receives: Device: NeuroPace® RNS® System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spectral power analysis and oscillatory properties

    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)

    Measured: Baseline

  2. Spectral power analysis and oscillatory properties

    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)

    Measured: through study completion, an average of 1 year

  3. Cross-frequency coupling and power coherence comodulograms

    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.

    Measured: Baseline

  4. Cross-frequency coupling and power coherence comodulograms

    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.

    Measured: through study completion, an average of 1 year

  5. Region of Interest analysis (FDG PET)

    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)

    Measured: Baseline

  6. Region of Interest analysis (FDG PET)

    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)

    Measured: After initial exposure session

  7. Region of Interest analysis (FDG PET)

    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)

    Measured: 12 months post-operatively

  8. Alpha rhythm frequency (EEG)

    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)

    Measured: Baseline

  9. Alpha rhythm frequency (EEG)

    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)

    Measured: monthly after implantation for the first year

  10. Alpha rhythm frequency (EEG)

    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)

    Measured: quarterly during year 2-4

  11. Source localization (EEG)

    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.

    Measured: Baseline

  12. Source localization (EEG)

    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.

    Measured: through study completion, an average of 1 year

Secondary outcomes (49)

  1. Clinician Administered PTSD Scale

    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.

    Measured: Baseline

  2. Clinician Administered PTSD Scale

    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.

    Measured: monthly after implantation for the first year

  3. Occurrence of adverse events

    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.

    Measured: through study completion, an average of 1 year

  4. Psychological scales (HAMA)

    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

    Measured: Baseline

  5. Psychological scales (HAMA)

    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

    Measured: monthly after implantation for the first year

  6. Psychological scales (HAMA)

    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

    Measured: every three months up to 48 months after baseline

  7. Psychological scales (MADRS)

    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

    Measured: Baseline

  8. Psychological scales (MADRS)

    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

    Measured: monthly after implantation for the first year

  9. Psychological scales (MADRS)

    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

    Measured: every three months up to 48 months after baseline

  10. Psychological scales (YBOC)

    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

    Measured: Baseline

  11. Psychological scales (YBOC)

    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

    Measured: monthly after implantation for the first year

  12. Psychological scales (YBOC)

    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

    Measured: every three months up to 48 months after baseline

  13. Digit Span subtest

    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

    Measured: Baseline

  14. Digit Span subtest

    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

    Measured: Months 6, 12, 24 and 48

  15. Trail Making Test A and B

    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

    Measured: Baseline

  16. Trail Making Test A and B

    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

    Measured: Months 6, 12, 24 and 48

  17. Ruff Figural Fluency Test (RFFT)

    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

    Measured: Baseline

  18. Ruff Figural Fluency Test (RFFT)

    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

    Measured: Months 6, 12, 24 and 48

  19. Brief Visual Memory Test

    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

    Measured: Baseline

  20. Brief Visual Memory Test

    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

    Measured: Months 6, 12, 24 and 48

  21. Revised (BVMT-R)

    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

    Measured: Baseline

  22. Revised (BVMT-R)

    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

    Measured: Months 6, 12, 24 and 48

  23. California Verbal Learning Test

    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

    Measured: Baseline

  24. California Verbal Learning Test

    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

    Measured: Months 6, 12, 24 and 48

  25. Attention, Processing Speed and Memory: Wechsler Adult Intelligence Scale IV (WAIS-IV)143 - Digit Span subtest, Trail Making Test A and B, Ruff Figural Fluency Test (RFFT), Brief Visual Memory Test - Revised (BVMT-R), California Verbal Learning Test

    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

    Measured: Baseline

  26. Attention, Processing Speed and Memory: Wechsler Adult Intelligence Scale IV (WAIS-IV)143 - Digit Span subtest, Trail Making Test A and B, Ruff Figural Fluency Test (RFFT), Brief Visual Memory Test - Revised (BVMT-R), California Verbal Learning Test

    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

    Measured: Months 6, 12, 24 and 48

  27. Wechsler Adult Intelligence Scale IV (WAIS-IV)

    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

    Measured: Months 6, 12, 24 and 48

  28. Wechsler Adult Intelligence Scale IV (WAIS-IV)

    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

    Measured: Baseline

  29. Wechsler Test of Adult Reading

    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

    Measured: Baseline

  30. Wechsler Test of Adult Reading

    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

    Measured: Months 6, 12, 24 and 48

  31. Controlled Oral Word Association (COWAT)

    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

    Measured: Baseline

  32. Controlled Oral Word Association (COWAT)

    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

    Measured: Months 6, 12, 24 and 48

  33. Hooper Visual Organization Test (VOT)

    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

    Measured: Baseline

  34. Hooper Visual Organization Test (VOT)

    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

    Measured: Months 6, 12, 24 and 48

  35. Rey-Osterrieth Complex Figure Test (CFT)

    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

    Measured: Baseline

  36. Rey-Osterrieth Complex Figure Test (CFT)

    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

    Measured: Months 6, 12, 24 and 48

  37. Wisconsin Card Sorting Test (WCST)

    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

    Measured: Baseline

  38. Wisconsin Card Sorting Test (WCST)

    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

    Measured: Months 6, 12, 24 and 48

  39. Stroop Color and Word Test

    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

    Measured: Baseline

  40. Stroop Color and Word Test

    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

    Measured: Months 6, 12, 24 and 48

  41. Iowa Gambling Task (IGT)

    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

    Measured: Baseline

  42. Iowa Gambling Task (IGT)

    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

    Measured: Months 6, 12, 24 and 48

  43. Montreal Cognitive Assessment (MOCA)

    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

    Measured: Baseline

  44. Montreal Cognitive Assessment (MOCA)

    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

    Measured: Months 6, 12, 24 and 48

  45. Frontal Systems/ Executive Functions: Wisconsin Card Sorting Test (WCST), Stroop Color and Word Test, Iowa Gambling Task (IGT)

    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

    Measured: Months 6, 12, 24 and 48

  46. Rey-15 Recognition test of Mental Effort

    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

    Measured: Months 6, 12, 24 and 48

  47. Rey-15 Recognition test of Mental Effort

    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

    Measured: Baseline

  48. SF-36V (quality of life)

    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

    Measured: Baseline

  49. SF-36V (quality of life)

    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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start22 Mar 2021
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04152993
Sponsor's protocol ID
UNS107673A
Status last verified
May 2024
First submitted
26 Oct 2019
Last updated
28 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The data obtained will be shared semi-annually. The data shared will include de-identified raw scores on the assessments, PET study analysis and safety data (adverse events, EEG findings). We will insure the accuracy of the data being shared and we will work with the NCDT staff in order to confirm that we are submitting the data appropriately. We will also comply with the NIH Public Access Policy during any publication related to this study.

Publications

  • Gill JL, Schneiders JA, Stangl M, Aghajan ZM, Vallejo M, Hiller S, Topalovic U, Inman CS, Villaroman D, Bari A, Adhikari A, Rao VR, Fanselow MS, Craske MG, Krahl SE, Chen JWY, Vick M, Hasulak NR, Kao JC, Koek RJ, Suthana N, Langevin JP. A pilot study of closed-loop neuromodulation for treatment-resistant post-traumatic stress disorder. Nat Commun. 2023 May 24;14(1):2997. doi: 10.1038/s41467-023-38712-1.

    PubMed 37225710

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing NeuroPace® RNS® System in people with Post-Traumatic Stress Disorder, run by VA Greater Los Angeles Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sonja Hiller (3107947517, shiller@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spectral power analysis and oscillatory properties (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in