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Posttraumatic Stress DisorderNCT02091843

Deep Brain Stimulation of the Amygdala for Combat Post-Traumatic Stress Disorder

A study testing DBS of the Basolateral Nucleus of the Amygdala and Medtronic Activa PC DBS of the Basolateral Nucleus of the Amygdala in people with Posttraumatic 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Posttraumatic stress disorder (PTSD) affects approximately 30 % of American veterans returning from Iraq and Afghanistan. Although the current therapy is effective, a percentage of patients will fail to improve and will develop chronic treatment-resistant PTSD. Read more about this study

Who is it for?
Ages 25 to 70 years, men only
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
DBS of the Basolateral Nucleus of the Amygdala and Medtronic Activa PC DBS of the Basolateral Nucleus of the Amygdala
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jan 2014to 31 Dec 2025
Phase
Interventional
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 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male aged 25-70 years.
  • Able to give informed consent in accordance with institutional policies and participate in the 2-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.
  • Confirmation of combat trauma exposure via military record review and a Combat Exposure Scale score > 9.
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  • Minimum 5 year total illness duration, with no 6 month period of clinical remission during the 5 years prior to entry in the study.
  • Clinical record documentation of non-response to at least 2 of the following antidepressants, alone or in combination, at maximally tolerated FDA recommended doses for ≥ 6 months: sertraline, paroxetine, fluoxetine, citalopram, escitalopram, amitriptyline, imipramine, nortriptyline, desipramine, clomipramine, phenelzine, tranylcypromine, venlafaxine, mirtazapine. Antidepressant trials must include at least one SSRI and one SNRI or TCA at maximally tolerated FDA recommended doses for a minimum of 3 months.
  • A minimum 3 month trial of prazosin at 10 mg per day or, if less, maximally tolerated FDA recommended doses, unless considered contraindicated based on co-morbid medical conditions or concomitant medications.
  • Trial of at least 3 months of one of the following: lithium, divalproex sodium, carbamazepine, lamotrigine, olanzapine, risperidone, bupropion either alone or in conjunction with one or more of the agents in #8 and # 9 above.
  • 6 months of continuous individual psychotherapy, conducted at least twice monthly for minimum 45 minute sessions, and consisting of a) clinician- defined cognitive-behavioural psychotherapy directed toward reducing conditioned fear symptoms of PTSD; b) cognitive processing psychotherapy for PTSD; c) prolonged exposure therapy for PTSD (imaginal, in vivo, and/or virtual reality); or d) Eye movement desensitization and reprocessing therapy for PTSD including a trauma exposure component, with chart documentation of inadequate benefit despite concerted effort. Other forms of individual or group psychotherapy are permitted but not required for inclusion. (Patients who are unable to complete 6 months of psychotherapy may be included if 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 (cognitive behavioural, cognitive processing, prolonged exposure, eye movement desensitization) has been completed a minimum of 3 months prior to enrolment.
  • Minimum baseline CAPS17 of 85 at entry, with a) scores of at least 4 (combined frequency and severity) on at least one symptom from each cluster (intrusion, avoidance and hyperarousal); b) score of 5 or more on CAPS17 items 4 or 5 (intense psychological distress or physiological reactivity on exposure to a reminder of the traumatic event); and c) no questionable validity (QV) rating greater than 1 on any CAPS item.
  • 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.
  • Clinically significant impairment in social functioning due to PTSD, manifested by one or more of the following: a) 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; b) 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; c) 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
  • Cohabitation with a spouse or significant other adult person who a) can confirm the symptoms and impairment from PTSD and lack of significant symptomatic remission in the past 5 years; and b) is willing to participate with the study psychiatrist in answering questions for the life functioning in PTSD scale (LFIPS) at scheduled follow-up visits; and c) is willing to 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 these.
  • 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);
  • 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
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  • Patients with uncontrolled medical conditions (hypertension, diabetes, infection);
  • Uncontrolled chronic pain;
  • Baseline Montgomery Asberg Depression Rating Scale (MADRS) of ≥ 28;
  • Patients who are receiving anticoagulation therapy;
  • Significant abnormality on preoperative structural brain MRI;
  • ECT in the past 6 months;
  • Contraindications to MRIs or the need for recurrent body MRIs;
  • Immunosuppression;
  • Patients who are not appropriate candidate for general anesthesia and/or DBS surgery;
  • Current pursuit of new or increased disability compensation for PTSD;
  • Has cardiac pacemaker/defibrillator, implanted medication pump, intra- cardiac lines, any intracranial implants (aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulator;
  • Patient has had past cranial neurosurgery;
  • Patient unable to discontinue therapeutic diathermy;
  • Use of other investigational drugs or psychotropic herbs 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.

Jean-Philippe Langevin, MD contact

310 268-3463

jlangevin@mednet.ucla.edu

Ralph Koek, MD contact

800-516-4567 ext. 7547

ralph.koek@va.gov

United States1 site, 1 recruiting

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

    Jean-Philippe Langevin, MD, 310-268-3463, jlangevin@mednet.ucla.edu

    Jean-Philippe Langevin, MD

    Recruiting

Other trials in United States

About this study

Official title: Deep Brain Stimulation of the Amygdala for Combat Post-Traumatic Stress

Posttraumatic stress disorder (PTSD) affects approximately 30 % of American veterans returning from Iraq and Afghanistan. Although the current therapy is effective, a percentage of patients will fail to improve and will develop chronic treatment-resistant PTSD. Patients suffering from PTSD experience intense suffering, lack of productivity and a higher risk of suicide. Unfortunately, combat PTSD has a tendency to be resistant to current treatments.

The central goal of this project is to develop a new therapeutic strategy involving the placement of intracranial electrodes to treat the symptoms of PTSD. The project is based on recent evidence showing abnormal activity in a specific brain region of PTSD patients, thought to be responsible for the core symptoms of PTSD.

Being tested
DBS of the Basolateral Nucleus of the Amygdala, Medtronic Activa PC DBS of the Basolateral Nucleus of the Amygdala
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.

  • DBS of the Basolateral Nucleus of the AmygdalaProcedure or surgery

  • Medtronic Activa PC DBS of the Basolateral Nucleus of the AmygdalaDevice

Study groups in NCT02091843
Study groupRoleWhat they receive
DBS of the Amygdala-30 daysExperimentalDeep brain stimulation of the amygdala BLn starting at 30 days post-operatively.
Receives: Procedure: DBS of the Basolateral Nucleus of the Amygdala; Device: Medtronic Activa PC DBS of the Basolateral Nucleus of the Amygdala
DBS of the Amygdala-90 daysExperimentalDeep brain stimulation of the amygdala BLn starting at 90 days post-operatively.
Receives: Procedure: DBS of the Basolateral Nucleus of the Amygdala; Device: Medtronic Activa PC DBS of the Basolateral Nucleus of the Amygdala

What is being measured

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

  1. Frequency and Severity of all adverse events

    Measured: 1 year

Secondary outcomes (1)

  1. Clinician-Administered PTSD Scale

    Measured: 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 posted19 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2024 (estimated)
  4. Study completion31 Dec 2025 (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
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02091843
Sponsor's protocol ID
PCC121657
Status last verified
Oct 2022
First submitted
14 Mar 2014
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Langevin JP, De Salles AA, Kosoyan HP, Krahl SE. Deep brain stimulation of the amygdala alleviates post-traumatic stress disorder symptoms in a rat model. J Psychiatr Res. 2010 Dec;44(16):1241-5. doi: 10.1016/j.jpsychires.2010.04.022. Epub 2010 May 26.

    PubMed 20537659

  • Stidd DA, Vogelsang K, Krahl SE, Langevin JP, Fellous JM. Amygdala deep brain stimulation is superior to paroxetine treatment in a rat model of posttraumatic stress disorder. Brain Stimul. 2013 Nov;6(6):837-44. doi: 10.1016/j.brs.2013.05.008. Epub 2013 Jun 25.

    PubMed 23835167

Questions about this trial

What is this clinical trial studying?

A study testing DBS of the Basolateral Nucleus of the Amygdala and Medtronic Activa PC DBS of the Basolateral Nucleus of the Amygdala in people with Posttraumatic 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 18 inclusion and 22 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 14 Oct 2022. 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.

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 Jean-Philippe Langevin, MD (310 268-3463, jlangevin@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and Severity of all adverse events (time frame: 1 year). 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 NCT02091843, which also lists 2 linked publications.

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 14 Oct 2022.

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