Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 155 for:    neurofeedback

fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03595293
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Hobkirk, Milton S. Hershey Medical Center

Brief Summary:
This study will examine the impact of functional near-infrared spectroscopy-based neurofeedback to a region within the brain's prefrontal cortex involved with self-regulation of resisting craving in alcohol use and prescription opioid use disorder patients. Participants will be asked to complete two cue reactivity tasks, six sessions of neurofeedback training as well as craving visual analog scales and self-efficacy questionnaires throughout a two-week period of their time in residential treatment at the Caron Treatment Center. They will be followed for 90 days after treatment completion at Caron to assess the impact neurofeedback had on their ability to remain sober once patients are living back in the "real world".

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcoholism Prescription Drug Dependence Opioid-use Disorder Neurofeedback Device: fNIRs-based Neurofeedback Device: Sham feedback Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Functional Near Infrared Spectroscopy-based Neurofeedback to Reduce Relapse in Prescription Opioid/Alcohol Use Disorders
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Experimental Group for AUD Patients
Patients will undergo six NFB sessions from the rDLPFC using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with an alcohol image, blocking them from progressing through the maze. When patients encounter the alcohol image and they increase activity in their rDLPFC, the image in the maze will decrease in size and vice versa. The size of the alcohol image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the rDLPFC will be sampled every 500 milliseconds using COBI studio software.
Device: fNIRs-based Neurofeedback
Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.

Sham Comparator: Sham Feedback Group for AUD Patients
Patients will undergo six sham feedback sessions from the skin over the zygomatic arch using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with an alcohol image, blocking them from progressing through the maze. When participants encounter the alcohol image and they increase blood supply over the zygomatic area, the image will decrease in size and vice versa. The size of the alcohol image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the zygomatic area will be sampled every 500 milliseconds using COBI studio software.
Device: Sham feedback
Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.

Experimental: Experimental Group for pOUD Patients
Patients will undergo six NFB sessions from the rDLPFC using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with a pill image, blocking them from progressing through the maze. When patients encounter the pill image and they increase activity in their rDLPFC, the image in the maze will decrease in size and vice versa. The size of the pill image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the rDLPFC will be sampled every 500 milliseconds using COBI studio software.
Device: fNIRs-based Neurofeedback
Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.

Sham Comparator: Sham Feedback Group for pOUD Patients
Patients will undergo six sham feedback sessions from the skin over the zygomatic arch using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with a pill image, blocking them from progressing through the maze. When participants encounter the pill image and they increase blood supply over the zygomatic area, the image will decrease in size and vice versa. The size of the pill image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the zygomatic area will be sampled every 500 milliseconds using COBI studio software.
Device: Sham feedback
Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.




Primary Outcome Measures :
  1. Improved capacity to increase neural activity in response to alcohol/pill cues in the rDLPFC measured by the change in the blood-oxygen level dependent (BOLD) signal [ Time Frame: First two weeks of protocol ]
  2. Increase in fNIRs signal response to pill/alcohol cues from pre-to-post neurofeedback sessions. [ Time Frame: First two weeks of protocol ]
    Increase in neural activation in the rDLPFC when viewing alcohol cues from the first neurofeedback session to the sixth (last) session.

  3. Higher levels of abstinence 90-days post-residential treatment completion as assessed by the 7-day timeline followback questionnaires. [ Time Frame: First 90 days after treatment completion at Caron Treatment Center ]
    7-day timeline followback questionnaire will be sent out every week for 12 weeks to assess abstinence


Secondary Outcome Measures :
  1. Change in self-reported self-efficacy from pre-to-post neurofeedback sessions assessed via the brief situational confidence questionnaire. [ Time Frame: First two weeks of protocol ]
    Before and after each neurofeedback session, participants will complete a brief situational confidence questionnaire

  2. Change in self-reported craving from pre-to-post neurofeedback sessions assessed via a 100-point craving visual analog scale. [ Time Frame: First two weeks of protocol ]
    Before and after each neurofeedback session, participants will complete a 100-point craving visual analog scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sex: male or female
  • Age: greater than or equal to 18 years
  • Caron Treatment Center residential patients with alcohol use disorder, moderate to severe (equivalent to Alcohol Dependence in DSM-IV-TR), or prescription opioid use disorder (pOUD)
  • Fluent in written and spoken English
  • Patients who are right-handed
  • Valid email address and reliable internet access after leaving the Caron Treatment Center

Exclusion Criteria:

  • Patients who are concurrently receiving a psychoactive drug for the treatment of an Axis I disorder.
  • Patients with current major depressive disorder or schizophrenia, bipolar disorder, post-traumatic stress disorder, or a history of traumatic brain injury.
  • Decisional impairment
  • Adults unable to consent
  • Women who are pregnant
  • Prisoners
  • Patients who are left-handed
  • No reliable email addresses

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): NCT03595293


Contacts
Layout table for location contacts
Contact: Sarah E Tilden, B.S. 7175310003 ext 286287 stilden@pennstatehealth.psu.edu
Contact: Andrea Hobkirk, PhD ahobkirk@pennstatehealth.psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Andrea Hobkirk, PhD Milton S. Hershey Medical Center

Layout table for additonal information
Responsible Party: Andrea Hobkirk, Assistant Professor of Psychiatry and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03595293     History of Changes
Other Study ID Numbers: 8203
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Andrea Hobkirk, Milton S. Hershey Medical Center:
Prescription Opioid Use Disorder
Alcohol Use Disorder
Functional Near-infrared Spectroscopy
Treatment Outcome
Resisting Craving

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Alcohol Drinking
Alcoholism
Substance-Related Disorders
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs