Post-Traumatic Stress Disorder (PTSD)NCT04891614
The PRISM Pilot Trial for Post-Traumatic Stress Disorder
A study testing PRISM in people with Post-Traumatic Stress Disorder (PTSD), run by GrayMatters Health Ltd. at 5 sites in 2 countries.
Trial summary
A Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and Effectiveness of Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to Standard of Care, in Subjects with Post-Traumatic Stress Disorder (PTSD) Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder (PTSD)
- What is being tested?
- PRISM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 29 Nov 2020to 1 Jun 2022
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 22 to 65
- Any gender
- Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- 1 to 20 years since index trauma
- Ability to give signed, informed consent
- Normal or corrected-to-normal vision
- Normal or corrected to normal hearing
- Subject is able to adhere to the study schedule
Who cannot join
- Have completed two or more full courses of trauma-focused therapy in the past (i.e., EMDR, Prolong Exposure Therapy, etc.), eligibility will be deemed upon the clinical judgment of the investigator.
- Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder
- Any mood disorder and anxiety disorder according to DSM-5 (in addition to those described in Exclusion 2) that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgment of the investigator
- Lifetime diagnosis of autism, mental retardation at the discretion of the investigator.
- Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit (as defined in DSM-5-substance use disorder) or at screening visit
- Any prescribed Benzodiazepine which cannot be ceased for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or which cannot be replaced with short-acting benzodiazepines that are taken only for sleeping during the night
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- Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs)
- Any change in or initiation of- SSRIs or SNRIs antidepressants within the past 4 weeks. At the time of recruitment, subjects must have no intention of changing their medication or psychotherapy during the study duration
- Any suicidal behavior in the past 1 year (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to screening and during the screening period
- Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy [CPT], Prolonged Exposure [PE], Eye Movement Desensitization and Reprocessing [EMDR]); continuation of established maintenance supportive therapy will be permitted
- Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury [TBI] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)
- Any unstable medical condition, as per the clinical judgement of the investigator
- In process of establishing/changing governmental/institutional compensation payments for PTSD symptoms
- Enrollment in another clinical study at screening or within 2 months prior to screening, or intended enrollment within the duration of this study
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Israel4 sites
Barzilai Medical Center
Ashkelon
Rambam Health Care Campus
Haifa, 3109601
Mental Health Center in Be'er Ya'akov
Ness Ziona, 70350
Sheba Medical Center
Ramat Gan, 52621
About this study
Official title: THE PRISM-PTSD PILOT TRIAL (Process-Instructed Self Neuro-Modulation ("Prism") Pilot Trial for Post-Traumatic Stress Disorder)
A Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and Effectiveness of Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to Standard of Care, in Subjects with Post-Traumatic Stress Disorder (PTSD)
Read the detailed description
Prism is a software device intended for neurofeedback (NF) training (i.e. operant condition based on EEG signals, also known as EEG-biofeedback), to be used in combination with a standard computer and supported EEG hardware. For purposes of this training, information for feedback is derived and processed from several EEG channels. Prism provides visual and/or auditory signals that correspond to the patient's computed EEG signal, which serves as a surrogate indicator of achieving a state of reduced amygdala activity.
The study is a Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and Effectiveness of Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to Standard of Care, in Subjects with Post-Traumatic Stress Disorder (PTSD).
The study population will include subjects diagnosed with Post-Traumatic Stress Disorder (PTSD) from 1 year to 20 years after index trauma. The total expected enrollment is up to 100 subjects in one or more sites.
The study's primary objective is to assess the safety and effectiveness of fifteen (15) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms.
- Conditions
- Post-Traumatic Stress Disorder (PTSD)
- Being tested
- PRISM
- Keywords
- PTSD
- 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.
PRISMDevice
Subjects will complete 15 neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects diagnosed with PTSD will be recruited from the community and from local clinical programs. All subjects will undergo Prism neurofeedback training. Receives: Device: PRISM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS - 5)
The primary objective of this study is to assess the proportion of subjects who demonstrate clinically meaningful improvement in the Clinician Administered PTSD Scale (CAPS - 5) score from Baseline to the 3 months follow-up visit. Clinically meaningful improvement is defined here as a 6-point reduction or more in the CAPS-5 score.
Measured: Baseline visit (Week 1) and 3 month Follow-up visit
Secondary outcomes (4)
PCL-5 response rate
To assess the proportion of subjects who demonstrate clinically meaningful improvement in the PTSD Checklist for DSM-5 (PCL-5). Clinically meaningful improvement is defined here as a 10-point reduction or more in the PCL-5 score
Measured: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
ERQ score
Change from baseline to Month 3 visit in ERQ score
Measured: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
PHQ-9 score
Change from baseline to Month 3 visit in PHQ-9 score
Measured: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
Clinical Global Impression (CGI)
Change from baseline to Month 3 visit in CGI score
Measured: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start29 Nov 2020
- Primary completion31 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm, open-label study
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- GrayMatters Health Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adar Shani, Study director, GrayMatters Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891614
- Sponsor's protocol ID
- CLP001
- Status last verified
- Apr 2022
- First submitted
- 6 May 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE PRISM-PTSD PILOT TRIAL (Process-Instructed Self Neuro-Modulation ("Prism") Pilot Trial for Post-Traumatic Stress Disorder)
- ClinicalTrials.gov ID
- NCT04891614
- Acronym / sponsor ID
- CLP001
- Conditions
- Post-Traumatic Stress Disorder (PTSD)
- Keywords
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- GrayMatters Health Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and Effectiveness of Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to Standard of Care, in Subjects with Post-Traumatic Stress Disorder (PTSD)
Detailed description
Prism is a software device intended for neurofeedback (NF) training (i.e. operant condition based on EEG signals, also known as EEG-biofeedback), to be used in combination with a standard computer and supported EEG hardware. For purposes of this training, information for feedback is derived and processed from several EEG channels. Prism provides visual and/or auditory signals that correspond to the patient's computed EEG signal, which serves as a surrogate indicator of achieving a state of reduced amygdala activity.
The study is a Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and Effectiveness of Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to Standard of Care, in Subjects with Post-Traumatic Stress Disorder (PTSD).
The study population will include subjects diagnosed with Post-Traumatic Stress Disorder (PTSD) from 1 year to 20 years after index trauma. The total expected enrollment is up to 100 subjects in one or more sites.
The study's primary objective is to assess the safety and effectiveness of fifteen (15) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, open-label study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: PRISMSubjects diagnosed with PTSD will be recruited from the community and from local clinical programs. All subjects will undergo Prism neurofeedback training. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 22 to 65
- Any gender
- Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- 1 to 20 years since index trauma
- Ability to give signed, informed consent
Key exclusion criteria (15 listed)
- Have completed two or more full courses of trauma-focused therapy in the past (i.e., EMDR, Prolong Exposure Therapy, etc.), eligibility will be deemed upon the clinical judgment of the investigator.
- Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder
- Any mood disorder and anxiety disorder according to DSM-5 (in addition to those described in Exclusion 2) that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgment of the investigator
- Lifetime diagnosis of autism, mental retardation at the discretion of the investigator.
- Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit (as defined in DSM-5-substance use disorder) or at screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRISMSubjects will complete 15 neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks. | Device | Treatment |
Primary outcome
Clinician Administered PTSD Scale (CAPS - 5)
Time frame: Baseline visit (Week 1) and 3 month Follow-up visit
The primary objective of this study is to assess the proportion of subjects who demonstrate clinically meaningful improvement in the Clinician Administered PTSD Scale (CAPS - 5) score from Baseline to the 3 months follow-up visit. Clinically meaningful improvement is defined here as a 6-point reduction or more in the CAPS-5 score.
4 secondary outcomes
PCL-5 response rate
Time frame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
ERQ score
Time frame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
PHQ-9 score
Time frame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
Clinical Global Impression (CGI)
Time frame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adar Shani study director
GrayMatters Health
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISM in people with Post-Traumatic Stress Disorder (PTSD), run by GrayMatters Health Ltd. at 5 sites in 2 countries.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS - 5) (time frame: Baseline visit (Week 1) and 3 month Follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2022.