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Connectivity-based Neurofeedback
Connectivity-based neurofeedback for Post-Traumatic Stress Disorder
N/A
Waitlist Available
Led By Ruth A Lanius, MD, PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1hour
Awards & highlights
Study Summary
This trial will use fMRI to help people with PTSD regulate their emotions during symptom induction.
Eligible Conditions
- Post Traumatic Stress Disorder
- Post-Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in emotional experience over neurofeedback training (RSDI scale)
Changes in functional magnetic resonance imaging (fMRI) neural connectivity/activation
Secondary outcome measures
Changes in PTSD symptoms over neurofeedback training (PCL-5)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental neurofeedback armExperimental Treatment1 Intervention
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).
Group II: Sham-control neurofeedback armPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
658 Previous Clinical Trials
413,658 Total Patients Enrolled
Ruth A Lanius, MD, PhDPrincipal InvestigatorLawson Health Research Institute
1 Previous Clinical Trials
124 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be between 18 and 65 years old.You have a history of experiencing severe mental health issues such as hallucinations or delusions.You cannot have any current or past mental health disorders if you are in the control group.You have received a lot of therapy in the past or are currently undergoing extensive therapy.You have been diagnosed with PTSD by the study assessment.You have a history of a neurological disorder.You are currently taking a lot of narcotic medications for a long time.You have a history of a developmental disorder that affects your ability to function in daily life.You have had problems with alcohol or drugs within the past 3 months.You have had a serious head injury in the past with a long period of unconsciousness.You have a history of bipolar disorder and are part of the PTSD group.You have been taking a lot of medications for mental health or pain management.
Research Study Groups:
This trial has the following groups:- Group 1: Sham-control neurofeedback arm
- Group 2: Experimental neurofeedback arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must individuals meet to be eligible for this research project?
"Eligible patients for this trial must present with moral injury and fall between 18 to 65 years of age. The study is seeking an approximate total of 120 participants."
Answered by AI
Does this research protocol include septuagenarians as potential test subjects?
"This study requires participants to be over the age of consent and below 65 years old."
Answered by AI
Are there any available opportunities for enrolment in this trial?
"As per clinicaltrials.gov, this medical trial is no longer seeking candidates for participation. The initial post date was on December 1st 2022 with the last update occurring August 25th of that same year. Despite not being able to join this particular study, there are currently 416 other studies recruiting patients."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
London Health Sciences Centre - University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Ontario
How many prior treatments have patients received?
0
How responsive is this trial?
Most responsive sites:
- London Health Sciences Centre - University Hospital: < 48 hours
Typically responds via
Phone Call
Email
Average response time
- < 2 Days
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