PTSDNCT04875221
Network-based Neurofeedback in PTSD
A study testing Connectivity-based neurofeedback in people with PTSD and Post-traumatic Stress Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This project will examine the use of real-time fMRI (rt-fMRI) neurofeedback in the regulation of neural networks underlying symptoms experienced by individuals with posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Post-traumatic Stress Disorder
- What is being tested?
- Connectivity-based neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2023to Sep 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PTSD Group:
- English speaking
- age: 18-65
- meets diagnostic criteria for PTSD (as determined by study assessment)
- Control Group:
- English speaking
- age: 18-65
Who cannot join
- All participants:
- Individuals with any implants, conditions, etc. that do not comply with 3-Tesla fMRI research safety standards (e.g., certain implants, pregnancy)
- history of neurological disorder
- history of any pervasive developmental disorder
- history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score < 15 at the time of incident assessed retrospectively by participant)
- significant untreated medical illness
Show all 15Show fewer
- alcohol/substance abuse or dependence within the last 3 months
- PTSD Group:
- history of bipolar disorder
- history of psychosis
- extensive current use of narcotic medications
- Control Group:
- any current or past mental health disorders
- extensive current or past psychotherapy
- extensive current or past use of psychotropic or narcotic medications
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - University Hospital
London, Onatrio, N6A 5A5
About this study
Official title: Mechanisms of Network-based Real-time fMRI Neurofeedback in Patients With Posttraumatic Stress Disorder
This project will examine the use of real-time fMRI (rt-fMRI) neurofeedback in the regulation of neural networks underlying symptoms experienced by individuals with posttraumatic stress disorder (PTSD). Investigators will use rt-fMRI neurofeedback in order to facilitate emotion regulation during symptom induction, and examine individual differences that influence regulation capacities.
Read the detailed description
The purpose of this study is to examine the mechanisms of real-time fMRI (rt-fMRI) neurofeedback as a method by which to regulate functional brain connections underlying symptoms/emotions experienced by individuals with PTSD. The aim of this study is to evaluate further the suitability of state-of-the-art fMRI as a non-invasive therapeutic tool among individuals burdened by PTSD, in order to inform future clinical trials of neurofeedback aiming to reduce symptoms of PTSD. This will be achieved by using rt-fMRI and neurofeedback of brain signals, in order to teach individuals with PTSD to self-regulate the neural networks that are associated with their symptoms. Investigators will examine the mechanisms of self-regulating neural networks using real-time neuroimaging and feedback to these brain signals. Neurofeedback is a form of brain training that allows individuals to improve their health by learning to control signals from their own body.
This study will employ a 2 (PTSD group vs. healthy control group) by 2 (arm; experimental vs. sham-control) design. This study involves an assessment which will include clinical interviews and a fMRI (functional magnetic resonance imaging) scan. The fMRI scan will involve trauma-word exposure during neurofeedback task runs. During the presentation of the words in the fMRI scanner, participants in the experimental arm will be able to view a feedback display that informs them of the strength of connectivity between the target regions. Participants in the sham-control arm will receive yoked sham neurofeedback signal (or fake signal), corresponding to a replayed feedback signal from a successful participant in the experimental group in order to ensure similar motivational states and following standard methods. In both arms, feedback signals will be relayed back to the participant in the scanner through visualization software as a thermometer that increases or decreases as the extent to which the target model dominates.
- Conditions
- PTSD, Post-traumatic Stress Disorder
- Being tested
- Connectivity-based neurofeedback
- Keywords
- Neurofeedback, NFB
- 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.
Connectivity-based neurofeedbackCombination product
Real-time fMRI neurofeedback will be used to non-invasively regulate neural network connectivity patterns associated with symptoms and emotional arousal among patients with PTSD and healthy individuals, with the aim to induce lasting neuronal effects and reduce symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Experimental neurofeedback arm | Experimental | The experimental arm will be able to view a feedback display that informs them of the strength of connectivity between the target regions. In both arms, feedback signals will be relayed back to the participant in the scanner through visualization software as a thermometer that increases or decreases as the extent to which the neural target model dominates (in other words, as the strength of directed connectivity between regions increases). Receives: Combination Product: Connectivity-based neurofeedback |
| Sham-control neurofeedback arm | Sham comparator | Participants in the sham-control arm will receive yoked sham neurofeedback signal (or fake signal), corresponding to a replayed feedback signal from a successful participant in the experimental group in order to ensure similar motivational states and following standard methods. Receives: Combination Product: Connectivity-based neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional magnetic resonance imaging (fMRI) neural connectivity/activation
Investigators will evaluate changes in fMRI neural connectivity and activation as a function of neurofeedback treatment. Specifically, investigators will evaluate changes in fMRI neural connectivity/activity among brain areas included in the neurofeedback target network (which includes areas within the default mode, salience, and central executive networks).
Measured: 1hour
Changes in emotional experience over neurofeedback training (RSDI scale)
The Response to Script Driven Imagery (RSDI) Scale will assess changes in symptoms after each neurofeedback run in the scanner (3 training runs), in line with previous neurofeedback studies. Investigators will evaluate changes in emotional experience during neurofeedback treatment and at 1-week follow-up, using the RSDI scale. The RSDI has a minimum value of 0 and maximum value of 66 (higher scores indicate more severe symptoms/emotional distress).
Measured: 1-week
Secondary outcomes (1)
Changes in PTSD symptoms over neurofeedback training (PCL-5)
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment.
Investigators will evaluate changes in PTSD symptoms from baseline, to post-neurofeedback training and at 1-week follow-up using the PCL-5. The minimum score is 0, the maximum is 80 (higher scores indicate increased PTSD severity).
Measured: 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Oct 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Study is no longer being conducted by Dr. Lanius - the principal investigator has been changed from Dr. Ruth Lanius to Dr. Andrew Nicholson.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the experimental or sham arms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Lanius, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Ruth A Lanius, MD, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875221
- Sponsor's protocol ID
- 9004
- Status last verified
- Sep 2023
- First submitted
- 27 Apr 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Network-based Real-time fMRI Neurofeedback in Patients With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04875221
- Acronym / sponsor ID
- 9004
- Conditions
- PTSD, Post-traumatic Stress Disorder
- Keywords
- Neurofeedback, NFB
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is no longer being conducted by Dr. Lanius - the principal investigator has been changed from Dr. Ruth Lanius to Dr. Andrew Nicholson.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 6 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.
This project will examine the use of real-time fMRI (rt-fMRI) neurofeedback in the regulation of neural networks underlying symptoms experienced by individuals with posttraumatic stress disorder (PTSD). Investigators will use rt-fMRI neurofeedback in order to facilitate emotion regulation during symptom induction, and examine individual differences that influence regulation capacities.
Detailed description
The purpose of this study is to examine the mechanisms of real-time fMRI (rt-fMRI) neurofeedback as a method by which to regulate functional brain connections underlying symptoms/emotions experienced by individuals with PTSD. The aim of this study is to evaluate further the suitability of state-of-the-art fMRI as a non-invasive therapeutic tool among individuals burdened by PTSD, in order to inform future clinical trials of neurofeedback aiming to reduce symptoms of PTSD. This will be achieved by using rt-fMRI and neurofeedback of brain signals, in order to teach individuals with PTSD to self-regulate the neural networks that are associated with their symptoms. Investigators will examine the mechanisms of self-regulating neural networks using real-time neuroimaging and feedback to these brain signals. Neurofeedback is a form of brain training that allows individuals to improve their health by learning to control signals from their own body.
This study will employ a 2 (PTSD group vs. healthy control group) by 2 (arm; experimental vs. sham-control) design. This study involves an assessment which will include clinical interviews and a fMRI (functional magnetic resonance imaging) scan. The fMRI scan will involve trauma-word exposure during neurofeedback task runs. During the presentation of the words in the fMRI scanner, participants in the experimental arm will be able to view a feedback display that informs them of the strength of connectivity between the target regions. Participants in the sham-control arm will receive yoked sham neurofeedback signal (or fake signal), corresponding to a replayed feedback signal from a successful participant in the experimental group in order to ensure similar motivational states and following standard methods. In both arms, feedback signals will be relayed back to the participant in the scanner through visualization software as a thermometer that increases or decreases as the extent to which the target model dominates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the experimental or sham arms.
| Arm | Type | Receives |
|---|---|---|
| Experimental neurofeedback arm | Experimental | Combination Product: Connectivity-based neurofeedbackThe experimental arm will be able to view a feedback display that informs them of the strength of connectivity between the target regions. In both arms, feedback signals will be relayed back to the participant in the scanner through visualization software as a thermometer that increases or decreases as the extent to which the neural target model dominates (in other words, as the strength of directed connectivity between regions increases). |
| Sham-control neurofeedback arm | Sham comparator | Combination Product: Connectivity-based neurofeedbackParticipants in the sham-control arm will receive yoked sham neurofeedback signal (or fake signal), corresponding to a replayed feedback signal from a successful participant in the experimental group in order to ensure similar motivational states and following standard methods. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- age: 18-65
- meets diagnostic criteria for PTSD (as determined by study assessment)
- English speaking
- age: 18-65
Key exclusion criteria (15 listed)
- Individuals with any implants, conditions, etc. that do not comply with 3-Tesla fMRI research safety standards (e.g., certain implants, pregnancy)
- history of neurological disorder
- history of any pervasive developmental disorder
- history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score < 15 at the time of incident assessed retrospectively by participant)
- significant untreated medical illness
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 |
|---|---|---|
| Connectivity-based neurofeedbackReal-time fMRI neurofeedback will be used to non-invasively regulate neural network connectivity patterns associated with symptoms and emotional arousal among patients with PTSD and healthy individuals, with the aim to induce lasting neuronal effects and reduce symptoms. | Combination product | Experimental neurofeedback arm, Sham-control neurofeedback arm |
Primary outcome
Changes in functional magnetic resonance imaging (fMRI) neural connectivity/activation
Time frame: 1hour
Investigators will evaluate changes in fMRI neural connectivity and activation as a function of neurofeedback treatment. Specifically, investigators will evaluate changes in fMRI neural connectivity/activity among brain areas included in the neurofeedback target network (which includes areas within the default mode, salience, and central executive networks).
Changes in emotional experience over neurofeedback training (RSDI scale)
Time frame: 1-week
The Response to Script Driven Imagery (RSDI) Scale will assess changes in symptoms after each neurofeedback run in the scanner (3 training runs), in line with previous neurofeedback studies. Investigators will evaluate changes in emotional experience during neurofeedback treatment and at 1-week follow-up, using the RSDI scale. The RSDI has a minimum value of 0 and maximum value of 66 (higher scores indicate more severe symptoms/emotional distress).
1 secondary outcome
Changes in PTSD symptoms over neurofeedback training (PCL-5)
Time frame: 1-week
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 21 Sep 2023.
- 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.
Ruth A Lanius, MD, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connectivity-based neurofeedback in people with PTSD and Post-traumatic Stress Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 7 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: withdrawn, as of the sponsor's last update on 21 Sep 2023. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Changes in functional magnetic resonance imaging (fMRI) neural connectivity/activation (time frame: 1hour). The study lists 2 primary outcomes in all. 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 21 Sep 2023.