Overview

This trial is active, not recruiting.

Conditions stress, blood pressure
Treatments real-time functional magnetic resonance imaging neurofeedback (rt-fmri-nf), ambulatory training
Sponsor University Hospital, Basel, Switzerland
Collaborator University of Basel
Start date August 2013
End date December 2016
Trial size 31 participants
Trial identifier NCT01921088, NF1_137023_A

Summary

The purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) in regulating brain activity and psychophysiological functions.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Contingent RT-fMRI-NF of brain activity in the target region of interest
real-time functional magnetic resonance imaging neurofeedback (rt-fmri-nf) There are no specific branded names etc. associated with the intervention.
Subjects are provided with RT-fMRI-NF.
ambulatory training
Subjects are provided with an ambulatory training.
(Sham Comparator)
Sham RT-fMRI-NF of brain activity of previously recorded subject
real-time functional magnetic resonance imaging neurofeedback (rt-fmri-nf) There are no specific branded names etc. associated with the intervention.
Subjects are provided with RT-fMRI-NF.
ambulatory training
Subjects are provided with an ambulatory training.

Primary Outcomes

Measure
Blood pressure
time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Blood oxygenation level dependent signal of the target brain region of interest
time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

Secondary Outcomes

Measure
Feedback on adverse events during the scanner and ambulatory training
time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

Eligibility Criteria

Male participants from 18 years up to 65 years old.

Inclusion Criteria: - Sufficient spoken and written knowledge of English - Right-handedness - Access to smartphone - Availability to participate in the study Exclusion Criteria: - Color blindness - Presence of cardiovascular disease - Medication intake affecting cardiovascular function - Medical MRI contraindication

Additional Information

Official title Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions
Principal investigator Marion Tegethoff, PhD
Description The overall goal of the outlined study is to establish a real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and psychophysiological functions. About two weeks after the initial training session it will be estimated how stable training effects have been. The two weeks in between, subjects will receive ambulatory training of the strategies via a smartphone-based application.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.