Trial Outcomes & Findings for Machine Learning Neurofeedback for PTSD (NCT NCT03482466)

Last Updated: 2024-06-28

Results Overview

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview that can be used to determine: current (past month) diagnosis of PTSD, lifetime diagnosis of PTSD, PTSD symptoms over the past week. Scores range from 0 - 80, with higher scores indicating increased PTSD symptom severity. The full interview takes 45-60 minutes to administer. In addition to PTSD symptoms, questions target symptom onset and duration, subjective distress, impact of symptoms on social and occupational functioning, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The CAPS-5 produces reliable and valid scores with standard administration. It should be administered by qualified interviewers with formal training in structured clinical interviewing and differential diagnosis, a thorough understanding of the conceptual basis of PTSD, and detailed knowledge of the measure's features and conventions.

Recruitment status

TERMINATED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-06-28

Participant Flow

Study participants were enrolled during 2018, 2019 and 2020. Study enrollment was stopped in March 2020 due to COVID-19 social distancing protocols.

Participant milestones

Participant milestones
Measure	PTSD Patients Neurofeedback: Patients will be inside an MRI machine. They were trained using real time feedback from brain imaging to learn personal strategies to bring their brain to the CALM state.
Overall Study STARTED	14
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	PTSD Patients Neurofeedback: Patients will be inside an MRI machine. They were trained using real time feedback from brain imaging to learn personal strategies to bring their brain to the CALM state.
Overall Study Protocol Violation	2

Baseline Characteristics

Machine Learning Neurofeedback for PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTSD Patients n=12 Participants Following assessment for eligibility and safety, study participants view an audiovisual stimulus called Bravemind, a virtual-world environment for military members simulating Iraq and Afghanistan. The interaction involves passive view of a virtual town with an appearance similar to those found in Iraq and Afghanistan. Events occur in the stimulus designed to evoke stress, such as smoke, explosions, and/or the appearance of enemy combatants. While viewing this environment, study participants are undergoing an fMRI scan and rating their level of stress on a 1-8 scale. There is no control group for this study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.00 years STANDARD_DEVIATION 9.94 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants
Clinician Administered PTSD Scale for DSM-5	37.08 units on a scale STANDARD_DEVIATION 9.19 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Data cannot be reported : Due to social distancing procedures implemented during the COVID-19 pandemic, only baseline data was collected for study participants. Thus, study participants were not assessed again at 6 weeks as originally planned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline at 6 weeks

Population: Outcomes could not be measured because the protocol was not completed due to unexpected complications including COVID-19. The investigators were unable to obtain the necessary measures. The investigators did not collect any heart rate data.

The investigators will collect heart rate data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Heart rate will be measured over time in beats per minute.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline at 6 weeks

Population: This outcome could not be measured because the protocol was not completed due to unexpected complications including COVID-19. The investigators did not collect any sleep data.

The investigators will collect sleep pattern data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Sleep patterns will be measured over time in number of wake events per night.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline at 6 weeks

Population: This outcome could not be measured because the protocol was not completed due to unexpected complications including COVID-19. The investigators did not collect any sleep data.

The investigators will collect total sleep data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Total sleep will be measured over time in minutes of sleep per day.

Outcome measures

Outcome data not reported

Adverse Events

PTSD Neurofeedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ramiro Salas

Baylor College of Medicine; Michael E. DeBakey VA Medical Center; Menninger Clinic

Phone: 7137983502

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place