Trial Outcomes & Findings for EEG Biofeedback Therapy as an Adjunct Treatment for PTSD (NCT NCT01591408)

Results Overview

Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning "not at all" and 10 being "extremely" anxious/irritable.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

68 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	EEG Biofeedback Subjects will receive EEG biofeedback according to their own brain rhythms EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.	Sham EEG Biofeedback Subjects will receive feedback according to someone else's brain rhythms collected during a different session. EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.
Overall Study STARTED	36	32
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	12	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EEG Biofeedback Therapy as an Adjunct Treatment for PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EEG Biofeedback n=24 Participants Subjects will receive EEG biofeedback according to their own brain rhythms EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.	Sham EEG Biofeedback n=24 Participants Subjects will receive feedback according to someone else's brain rhythms collected during a different session. EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.	Total n=48 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 5.2 • n=5 Participants	29.4 years STANDARD_DEVIATION 5.6 • n=7 Participants	29.9 years STANDARD_DEVIATION 5.4 • n=5 Participants
Gender Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Gender Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Subjects were active duty military with PTSD diagnosis currently in residential treatment facility

Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning "not at all" and 10 being "extremely" anxious/irritable.

Outcome measures

Outcome measures
Measure	EEG Biofeedback n=24 Participants Subjects will receive EEG biofeedback according to their own brain rhythms EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.	Sham EEG Biofeedback n=24 Participants Subjects will receive feedback according to someone else's brain rhythms collected during a different session. EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.
Improved Symptom Ratings Irritability	-2.62 Rating on scale Standard Deviation 2.40	-1.62 Rating on scale Standard Deviation 2.23
Improved Symptom Ratings Anxiety	-2.25 Rating on scale Standard Deviation 2.22	-1.21 Rating on scale Standard Deviation 2.23

Adverse Events

EEG Biofeedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham EEG Biofeedback

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

Julie Onton

NavalMCSD

Phone: 619-553-6228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place