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Neurofeedback Therapeutic Intervention For Post-Traumatic Stress Disorder Patients Compared To Treatment As Usual (NFTIP)

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ClinicalTrials.gov Identifier: NCT02544971
Recruitment Status : Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many individuals exposed to aversive events. The severity of PTSD symptoms is positively correlated with amygdala activation. More severe PTSD symptoms following exposure to stressful events, are associated with amygdala hyper-responsivity prior to exposure. A possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Previous work in our lab established a NF training procedure that utilizes the temporal abilities of EEG with the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to self-regulate amygdala activity and to improve emotional regulation in a healthy population. The current study aims to investigate the potential of this method as a therapeutic intervention for PTSD.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Neurofeedback Other: Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurofeedback Therapeutic Intervention For Post-Traumatic Stress Disorder Patients Compared To Treatment As Usual
Actual Study Start Date : April 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NF-N group
Neurofeedback in a neutral context
Behavioral: Neurofeedback
Neurofeedback is based on the learned change in a particular neural signal or a combination of neural signals when feedback and reward of these signals are repeatedly presented to the organism. Thus, individuals learn to modulate their neural activity through a closed NF loop.

Active Comparator: NF-T group
Neurofeedback in a trauma-related context
Behavioral: Neurofeedback
Neurofeedback is based on the learned change in a particular neural signal or a combination of neural signals when feedback and reward of these signals are repeatedly presented to the organism. Thus, individuals learn to modulate their neural activity through a closed NF loop.

Active Comparator: Control group
Treatment as usual
Other: Control
Treatment as usual




Primary Outcome Measures :
  1. Decreased PTSD symptoms measured by change in psychiatric evaluation and PCL score [ Time Frame: 1-14 weeks ]
    Psychiatric evaluation is based on amount and severity of symptoms according to DSM-IV/V. We will also base change in symptoms on a statistically significant change in PCL (PTSD Check List) score

  2. Reduced amygdala reactivity measured by percent change in BOLD signal [ Time Frame: 1-14 weeks ]

Secondary Outcome Measures :
  1. Change in Emotion Regulation Questionnaire (ERQ) [ Time Frame: 1-14 weeks ]
    36-item measure of cognitive coping strategies

  2. Change in State/Trait Anxiety Inventory (STAI) [ Time Frame: 1-14 weeks ]
    20-item measure of state & trait anxiety

  3. Change in Beck Depression Inventory (BDI-II) [ Time Frame: 1-14 weeks ]
    21-item measure of clinical depression



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic Post traumatic stress disorder (PTSD) (at least one year and two months since diagnosis; diagnosis according to DSM-V, or DSM-VI)
  • Patients must meet the criteria for medical MRI testing set by Tel Aviv Sourasky Medical Center

Exclusion Criteria:

  • Patients diagnosed with another major psychiatric disorder other than PTSD (such as schizophrenia).
  • Patients diagnosed with substance abuse.
  • Any aggravation of PTSD symptoms that requires hospitalization.
  • Patients who are unable to commit to the duration and plan of the study.
  • Patients who meet the criteria for exclusion in medical MRI scans, according to procedures set forth at MRI Medical Center in Tel-Aviv Sourasky. For example, metal that cannot be removed, orthodontal accessories connected to one's teeth, or current systemic diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544971


Locations
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Israel
Whol Institute for Advanced Imaging, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Talma Hendler, MD, PhD Tel Aviv University Sourasky Medical Center

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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02544971     History of Changes
Other Study ID Numbers: 0215-15-TLV
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders