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fMRI-Neurofeedback for PTSD

N/A

Recruiting

Research Sponsored by Andrew Nicholson

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 data collection will span 7-weeks during the study (i.e., 1-week baseline before neurofeedback session #1, 1-week between neurofeedback sessions #1 and #2, 1-week between neurofeedback sessions #2 and #3, 1-month follow-up after neurofeedback session #3)

Awards & highlights

Study Summary

This trial will investigate whether PTSD patients can use real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback to self-regulate aberrant neural circuitry associated with PTSD psychopathology.

Who is the study for?

This trial is for English-speaking adults aged 18-65 with PTSD, comfortable with tech like laptops and smartphones. Participants must have a PTSD diagnosis as per DSM-5 criteria but can also have depression or anxiety disorders. Exclusions include pregnancy, serious illnesses, MRI contraindications (like metal implants), neurological issues, untreated major illnesses, substance abuse in the last three months, claustrophobia, prior neurofeedback therapy or brain stimulation treatments.Check my eligibility

What is being tested?

The study tests if multiple sessions of real-time fMRI neurofeedback can help PTSD patients control abnormal brain activity linked to their condition. It compares two targets for feedback: the amygdala and posterior cingulate cortex against sham controls to see which affects symptoms and neural connectivity better.See study design

What are the potential side effects?

Since this trial involves non-invasive fMRI neurofeedback without drugs or surgery, side effects are minimal but may include discomfort from lying still during scans or emotional distress from focusing on traumatic memories during sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ data collection will span 7-weeks during the study (i.e., 1-week baseline before neurofeedback session #1, 1-week between neurofeedback sessions #1 and #2, 1-week between neurofeedback sessions #2 and #3, 1-month follow-up after neurofeedback session #3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~data collection will span 7-weeks during the study (i.e., 1-week baseline before neurofeedback session #1, 1-week between neurofeedback sessions #1 and #2, 1-week between neurofeedback sessions #2 and #3, 1-month follow-up after neurofeedback session #3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and data collection will span 7-weeks during the study (i.e., 1-week baseline before neurofeedback session #1, 1-week between neurofeedback sessions #1 and #2, 1-week between neurofeedback sessions #2 and #3, 1-month follow-up after neurofeedback session #3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in PTSD symptoms over neurofeedback training sessions

Region-of-interest (ROI) downregulation analysis over neurofeedback training sessions

Secondary outcome measures

Change in depressive symptoms (i.e., BDI-II) over neurofeedback training sessions

Dissociation

Change in emotion regulation abilities (i.e., DERS) over neurofeedback training sessions

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Sham-controlExperimental Treatment1 Intervention

PTSD participants will receive a sham neurofeedback signal, i.e., from a successful participant in one of the experimental arms.

Group II: Posterior cingulate cortex (PCC)Experimental Treatment1 Intervention

PTSD participants will receive a neurofeedback signal reflecting PCC activity.

Group III: AmygdalaExperimental Treatment1 Intervention

PTSD participants will receive a neurofeedback signal reflecting amygdala activity.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

McMaster UniversityOTHER

884 Previous Clinical Trials

2,598,256 Total Patients Enrolled

Western UniversityOTHER

26 Previous Clinical Trials

128,481 Total Patients Enrolled

Andrew NicholsonLead Sponsor

Media Library

MRI Biofeedback Clinical Trial Eligibility Overview. Trial Name: NCT05456958 — N/A

Post-Traumatic Stress Disorder Research Study Groups: Sham-control, Posterior cingulate cortex (PCC), Amygdala

Post-Traumatic Stress Disorder Clinical Trial 2023: MRI Biofeedback Highlights & Side Effects. Trial Name: NCT05456958 — N/A

MRI Biofeedback 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456958 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I become enrolled in this experiment?

"The clinical trial has a target sample size of 60 adults, ranging 18-65 years old who have experienced moral injury. To be eligible for the study, applicants must demonstrate fluency in English, familiarity with electronic devices such as laptops and smartphones, meet DSM-5 criteria for PTSD on CAPS-5 assessments (coexisting anxiety disorders or major depressive disorder are not grounds for exclusion), and give written informed consent."

Answered by AI

What is the ultimate aim of this clinical experiment?

"This research project will be evaluating the Change in ROI activation between neurofeedback sessions 1, 2, and 3. The primary outcome is Changes in PTSD symptoms over neurofeedback training sessions while secondary outcomes include changes to emotional states of depression, anxiety, and stress (DASS-21), interoceptive awareness (MAIA) as well as depressive symptoms (BDI). Data collection across all three parameters shall occur at each of the three training session intervals plus a one week follow-up period."

Answered by AI

Is this research endeavor currently enrolling participants?

"It appears that the data on clinicaltrials.gov reveals this study is not seeking out new candidates at present, as its post date was September 1st 2022 and it last edited July 11th 2022. However, there are currently 417 other medical trials actively enrolling individuals for treatment."

Answered by AI