PTSDSPrC-PTSDNCT04543513
Self-regulation of Prefrontal Cortex During Emotional Cognitive Control in PTSD
A study testing Real-time functional magnetic resonance neurofeedback (rtfMRI-nf) in people with PTSD and Cognitive Function, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
Deficits in emotional cognitive control are present in a number of clinical psychiatric populations including depression, anxiety, and PTSD. Deficits in this domain of function limit one's ability to focus attention on goal-directed activities while inhibiting reactions to irrelevant emotional stimuli, and this… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- PTSD, Cognitive Function
- What is being tested?
- Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Jun 2023
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- able to provide informed consent
- sufficient English proficiency to complete procedures
- primary DSM-5 psychiatric diagnosis of posttraumatic stress disorder (PTSD)
Who cannot join
- significant or unstable physical or mental health conditions (e.g., immediate suicidal intent) requiring medical attention
- meeting criteria in either the present or past for the following DSM-5 psychiatric disorders: Schizophrenia Spectrum and Other Psychotic Disorders, Obsessive- Compulsive disorders, or Bipolar and Related Disorders
- recent change (i.e., within 6 weeks) for prescription of psychiatric medication
- current, regular benzodiazepine use
- history of moderate to severe traumatic brain injury
- diagnosis of neurologic disorders
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- current alcohol/drug abuse
- MRI contra-indications (e.g., metal in body)
- uncorrected vision/hearing problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Deficits in emotional cognitive control are present in a number of clinical psychiatric populations including depression, anxiety, and PTSD. Deficits in this domain of function limit one's ability to focus attention on goal-directed activities while inhibiting reactions to irrelevant emotional stimuli, and this contributes to the symptoms of these disorders and makes individuals less likely to be successful in existing treatments. The left dorsolateral prefrontal cortex (LDLPFC) and its connectivity with other regions (i.e., dorsal anterior cingulate cortex, ventromedial prefrontal cortex, insula, amygdala) is thought to play a central role in facilitating emotional cognitive control. However, past research has primarily utilized correlational approaches that limit conclusions about the directionality of these relationships. Enhancing our understanding of the neural underpinnings of emotional cognitive control could be valuable for informing treatment for populations with deficits in these processes, such as adults with PTSD.
The current study utilizes a neuromodulatory approach called real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) whereby participants observe their own neural activity in the moment and are taught to self-regulate this activity. Adult volunteers, who have been diagnosed with PTSD, will be trained to increase neural activity in LDLPFC while involved in mental tasks involving emotional cognitive control processes. The mental tasks will include counting, remembering words, or planning events while viewing negatively-valenced emotional words (e.g., kill, death, threat). Participants in this study will complete a non-randomized LDLPFC rtfMRI-nf protocol to assess tolerability and feasibility of the protocol in a clinical population of interest. Resting-state fMRI scans and behavioral testing sessions will take place before and after rtfMRI-nf.
Read more
The specific aims are to examine the impact of LDLPFC rtfMRI-nf on: (1) LDLPFC activity during emotional cognitive control, (2) LDLPFC functional connectivity with other brain regions during rest, and (3) cognitive control task performance. As this study is meant to be preliminary, the target sample size is not powered to detect statistical significance for these measures. However, effect size estimates will be calculated to provide potential justification for future work with this protocol in this clinical population.
To these ends, this study will use rtfMRI-nf to examine preliminary evidence of a novel protocol to regulate LDLPFC activity in adults diagnosed with PTSD. This research will improve our understanding of emotional cognitive control and demonstrate whether this is a modifiable target for intervention in this clinical population of interest.
- Conditions
- PTSD, Cognitive Function
- Being tested
- Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)
- 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.
Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)Other
Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) is a procedure using an MRI scanner that allows participants to observe their own neural activity in the moment. They are taught to self-regulate this activity during a task.
| Study group | Role | What they receive |
|---|---|---|
| Active Left Dorsolateral Prefrontal Cortex rtfMRI-nf | Experimental | Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) will target left dorsolateral prefrontal cortex. Participants in this arm will receive active feedback while attempting to modulate their neural activity during an emotional cognitive control task. Receives: Other: Real-time functional magnetic resonance neurofeedback (rtfMRI-nf) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left dorsolateral prefrontal cortex activity during emotional cognitive control (pre- to post-neurofeedback)
Individual ability to regulate left dorsolateral prefrontal cortex activity during an emotional cognitive control task will be assessed before and after neurofeedback.
Measured: Approximately 2 hours after baseline assessment
Secondary outcomes (1)
Left dorsolateral prefrontal cortex functional connectivity with other brain regions during rest (pre- to post-neurofeedback)
Individual functional connectivity values between left dorsolateral prefrontal cortex and other brain regions during rest will be assessed before and after neurofeedback.
Measured: Approximately 2 hours after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jan 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Why it stopped: Changes to protocol are necessary to optimize engagement of neural target
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Aupperle, Laureate Institute for Brain Research, Inc.
- Investigators
- Robin L Aupperle, Ph.D., Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543513
- Sponsor's protocol ID
- 2019-012 - Part 2
- Acronym
- SPrC-PTSD
- Status last verified
- Aug 2022
- First submitted
- 2 Sep 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be released publicly, but requests for group-averaged results will be considered by individual request following publication of findings from this study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-regulation of Prefrontal Cortex During Emotional Cognitive Control in PTSD
- ClinicalTrials.gov ID
- NCT04543513
- Acronym / sponsor ID
- SPrC-PTSD / 2019-012 - Part 2
- Conditions
- PTSD, Cognitive Function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes to protocol are necessary to optimize engagement of neural target
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Sep 2020 (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.
Deficits in emotional cognitive control are present in a number of clinical psychiatric populations including depression, anxiety, and PTSD. Deficits in this domain of function limit one's ability to focus attention on goal-directed activities while inhibiting reactions to irrelevant emotional stimuli, and this contributes to the symptoms of these disorders and makes individuals less likely to be successful in existing treatments. The left dorsolateral prefrontal cortex (LDLPFC) and its connectivity with other regions (i.e., dorsal anterior cingulate cortex, ventromedial prefrontal cortex, insula, amygdala) is thought to play a central role in facilitating emotional cognitive control. However, past research has primarily utilized correlational approaches that limit conclusions about the directionality of these relationships. Enhancing our understanding of the neural underpinnings of emotional cognitive control could be valuable for informing treatment for populations with deficits in these processes, such as adults with PTSD.
The current study utilizes a neuromodulatory approach called real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) whereby participants observe their own neural activity in the moment and are taught to self-regulate this activity. Adult volunteers, who have been diagnosed with PTSD, will be trained to increase neural activity in LDLPFC while involved in mental tasks involving emotional cognitive control processes. The mental tasks will include counting, remembering words, or planning events while viewing negatively-valenced emotional words (e.g., kill, death, threat). Participants in this study will complete a non-randomized LDLPFC rtfMRI-nf protocol to assess tolerability and feasibility of the protocol in a clinical population of interest. Resting-state fMRI scans and behavioral testing sessions will take place before and after rtfMRI-nf.
The specific aims are to examine the impact of LDLPFC rtfMRI-nf on: (1) LDLPFC activity during emotional cognitive control, (2) LDLPFC functional connectivity with other brain regions during rest, and (3) cognitive control task performance. As this study is meant to be preliminary, the target sample size is not powered to detect statistical significance for these measures. However, effect size estimates will be calculated to provide potential justification for future work with this protocol in this clinical population.
To these ends, this study will use rtfMRI-nf to examine preliminary evidence of a novel protocol to regulate LDLPFC activity in adults diagnosed with PTSD. This research will improve our understanding of emotional cognitive control and demonstrate whether this is a modifiable target for intervention in this clinical population of interest.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Left Dorsolateral Prefrontal Cortex rtfMRI-nf | Experimental | Other: Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) will target left dorsolateral prefrontal cortex. Participants in this arm will receive active feedback while attempting to modulate their neural activity during an emotional cognitive control task. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- able to provide informed consent
- sufficient English proficiency to complete procedures
- primary DSM-5 psychiatric diagnosis of posttraumatic stress disorder (PTSD)
Key exclusion criteria (9 listed)
- significant or unstable physical or mental health conditions (e.g., immediate suicidal intent) requiring medical attention
- meeting criteria in either the present or past for the following DSM-5 psychiatric disorders: Schizophrenia Spectrum and Other Psychotic Disorders, Obsessive- Compulsive disorders, or Bipolar and Related Disorders
- recent change (i.e., within 6 weeks) for prescription of psychiatric medication
- current, regular benzodiazepine use
- history of moderate to severe traumatic brain injury
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 |
|---|---|---|
| Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) is a procedure using an MRI scanner that allows participants to observe their own neural activity in the moment. They are taught to self-regulate this activity during a task. | Other | Active Left Dorsolateral Prefrontal Cortex rtfMRI-nf |
Primary outcome
Left dorsolateral prefrontal cortex activity during emotional cognitive control (pre- to post-neurofeedback)
Time frame: Approximately 2 hours after baseline assessment
Individual ability to regulate left dorsolateral prefrontal cortex activity during an emotional cognitive control task will be assessed before and after neurofeedback.
1 secondary outcome
Left dorsolateral prefrontal cortex functional connectivity with other brain regions during rest (pre- to post-neurofeedback)
Time frame: Approximately 2 hours after baseline assessment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be released publicly, but requests for group-averaged results will be considered by individual request following publication of findings from this study.
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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.
Robin L Aupperle, Ph.D. principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time functional magnetic resonance neurofeedback (rtfMRI-nf) in people with PTSD and Cognitive Function, run by Laureate Institute for Brain Research, Inc. 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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 23 Aug 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Left dorsolateral prefrontal cortex activity during emotional cognitive control (pre- to post-neurofeedback) (time frame: Approximately 2 hours after baseline assessment). 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 23 Aug 2022.