2 March 2024
Amygdala-derived-EEG-fMRI-pattern neurofeedback for the treatment of chronic post-traumatic stress disorder. A prospective, multicenter, multinational study evaluating clinical efficacy.
/ Fruchter E, Goldenthal N, Adler LA, Gross R, Harel EV, Deutsch L, Nacasch N, Grinapol S, Amital D, Voigt JD, Marmar CR.
Psychiatry Research, Volume 333, 2024.
A prospective, single arm, multisite, multinational, open label trial assessing the safety and efficacy of Amygdala-derived EFP neurofeedback treatment for chronic PTSD. Participants, including veterans and civilians, underwent 15 neurofeedback sessions over 8 weeks and; baseline, termination (8 weeks) and 3 month post treatment assessments with validated measures.
The primary endpoint was met, with a CAPS-5 MCID response rate of 66.7 %. The average reduction in CAPS-5 total scores at 3 month follow up was 13.5 points, more than twice the MCID. Changes from baseline in CAPS-5, PCL-5, PHQ-9 scores at 8 weeks and the 3 month follow-up demonstrated statistically significant improvements in response and; demonstrated effect sizes ranging from 0.46 to 1.07. Adverse events were mild and resolved after treatment.
This study builds on prior research demonstrating similar outcomes using amygdala-derived neurofeedback. Positive attributes of this therapy include monitoring by non-physician personnel, affordability, accessibility, and tolerability.
To read the full article on Psychiatry Research - https://www.sciencedirect.com/science/article/pii/S0165178123006613
FAQS -
1. What was the design and primary endpoint of the study on amygdala‐derived EEG-fMRI pattern neurofeedback for chronic PTSD?
The study was a prospective, single‐arm, multisite, multinational, open-label study assessing the novel neurofeedback therapy in adults with chronic PTSD. Participants (both veterans and civilians) underwent 15 neurofeedback sessions over 8 weeks, with assessments at baseline, termination (8 weeks), and 3 months post‐treatment.
The primary endpoint was a clinically meaningful response on the CAPS‑5 (Clinician‐Administered PTSD Scale for DSM-5) defined as a 6-point or greater reduction in the CAPS-5 score (response rate).
2. What efficacy results did the study demonstrate for this neurofeedback intervention in chronic PTSD?
The study met its primary endpoint.The CAPS-5 response rate at 3 months was 66.7%. The average reduction in CAPS-5 total scores at the 3-month follow-up was 13.5 points, which is more than twice the MCID threshold. Additional measures, including the PCL‑5 (PTSD Checklist for DSM-5) and PHQ‑9 (for depressive symptoms), showed statistically significant improvements from baseline at 8 weeks and at the 3-month follow‐up, with effect sizes in the range of 0.46 to 1.07.
3. How was the intervention characterized in terms of practical implementation and tolerability?
The intervention is described as being monitored by non‐physician personnel, making it affordable, accessible, and well-tolerated. Adverse events were reported as mild and resolved after treatment, indicating a favorable safety profile within the study parameters.
4. From a scientific standpoint, what is the basis of using an amygdala-derived EEG-fMRI neurofeedback approach in chronic PTSD?
A recently developed, innovative technology integrates simultaneous EEG and fMRI recordings designated Amygdala-derived- EEG-fMRI-Pattern (EFP). The EFP is informed by fMRI data of the amygdala, a brain region that controls fear, emotional regulation, and key in PTSD symptomatology.
5. What are the implications and limitations of this study for clinical psychiatric practice at present?
Implications: The positive findings (response rate, symptom reduction, safety) suggest that this amygdala-derived EEG‐fMRI neurofeedback approach could be a promising adjunctive therapeutic option for chronic PTSD, especially where conventional treatments may be insufficient. Its monitoring by non‐physicians offers potential operational flexibility in clinical settings.
Limitations: As a single‐arm open-label trial, there was no control group, so conclusions about comparative efficacy and placebo effects remain limited. The summary does not report long-term durability beyond 3 months. Also, the logistics of combining EEG/fMRI neurofeedback may limit current widespread deployment. For psychiatrists considering integration, these factors, plus cost, availability of equipment/personnel, and patient selection criteria, will need careful evaluation.