- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02692196
Fronto-limbic Functional Connectivity Via Real-time fMRI Neurofeedback
November 7, 2017 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Voluntary Regulation of Fronto-limbic Functional Connectivity: A Proof-of-concept Real-time fMRI Study
Real-time fMRI neurofeedback training induced volitional control of brain activity and connectivity could help individuals to gain better control over their emotions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the present proof-of-concept study, investigators plan to evaluate whether real-time fMRI neurofeedback training can enable individuals to gain volitional control over their fronto-limbic circuitry.
Given that this circuitry has been abundantly implicated in emotional perception and regulation this could facilitate emotional control.
Suitable participants underwent fronto-limbic connectivity feedback training and sham training in a cross over design.
During both trainings participants are instructed to regulate the neural indices during feedback.
We expect that receiving fronto-limbic feedback enhances emotion regulation during the training.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- School of Life science and Technology, University of Electronic Science and Technology of China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy subjects without past or current psychiatric or neurological disorders
Exclusion Criteria:
- pregnant, taking oral contraceptives
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neurofeedback Training
Neurofeedback training - neurofeedback of fronto-limbic functional connectivity.
|
|
|
Sham Comparator: Sham Control
Sham training - feedback that is not related with fronts-limbic connectivity (motor connectivity)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neural indices of training success
Time Frame: three days
|
three days
|
|
|
Training-induced changes in emotion related processing
Time Frame: three days
|
The scores of visual analogue scale assessing individuals' anxiety level will be compared between before and after training within each group as well as between twe groups after training
|
three days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
February 17, 2016
First Submitted That Met QC Criteria
February 22, 2016
First Posted (Estimate)
February 25, 2016
Study Record Updates
Last Update Posted (Actual)
November 8, 2017
Last Update Submitted That Met QC Criteria
November 7, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UESTC-neuSCAN-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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