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EEG Biofeedback Therapy as an Adjunct Treatment for PTSD

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ClinicalTrials.gov Identifier: NCT01591408
Recruitment Status : Completed
First Posted : May 4, 2012
Results First Posted : December 20, 2016
Last Update Posted : December 20, 2016
Sponsor:
Collaborator:
Naval Health Research Center
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions PTSD
Anxiety
Trauma
Sleep Disorders
Intervention Device: EEG biofeedback
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EEG Biofeedback Sham EEG Biofeedback
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 36 32
Completed 24 24
Not Completed 12 8
Arm/Group Title EEG Biofeedback Sham EEG Biofeedback Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
30.4  (5.2) 29.4  (5.6) 29.9  (5.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
2
   8.3%
3
  12.5%
5
  10.4%
Male
22
  91.7%
21
  87.5%
43
  89.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 48 participants
24 24 48
1.Primary Outcome
Title Improved Symptom Ratings
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were active duty military with PTSD diagnosis currently in residential treatment facility
Arm/Group Title EEG Biofeedback Sham EEG Biofeedback
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: Rating on scale
Irritability -2.62  (2.40) -1.62  (2.23)
Anxiety -2.25  (2.22) -1.21  (2.23)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and Other (Not Including Serious) Adverse Events were not collected/assessed
 
Arm/Group Title EEG Biofeedback Sham EEG Biofeedback
Hide Arm/Group Description

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.

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.

All-Cause Mortality
EEG Biofeedback Sham EEG Biofeedback
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EEG Biofeedback Sham EEG Biofeedback
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EEG Biofeedback Sham EEG Biofeedback
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Julie Onton
Organization: NavalMCSD
Phone: 619-553-6228
Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01591408     History of Changes
Other Study ID Numbers: NMCSD.2012.0042
First Submitted: May 2, 2012
First Posted: May 4, 2012
Results First Submitted: August 23, 2016
Results First Posted: December 20, 2016
Last Update Posted: December 20, 2016