Nicotine DependenceNCT03165578
Neural Correlates of Neurofeedback Training
A study testing Neurofeedback training in people with Nicotine Dependence and Depression, run by Frank Scharnowski at 1 site in Switzerland.
Trial summary
The objective of the present study is to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence, Depression, PTSD
- What is being tested?
- Neurofeedback training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2017to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Magnetic resonance imaging compatibility.
- DSM-V diagnosis of major depressive disorder, post-traumatic stress disorder, or nicotine addiction, respectively.
Who cannot join
- Other physical or psychiatric disorders.
- Current substance abuse.
- Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Hospital of Psychiatry, University of Zurich
Zurich, Canton of Zurich, 8032
Frank Scharnowski, Prof. Dr., +41443842953, Frank.Scharnowski@uzh.ch
Ronald Sladky, PD Dr., +41443842667, ronald.sladky@uzh.ch
About this study
The objective of the present study is to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI.
Read the detailed description
Neurofeedback has been established as a promising non-pharmacological therapeutic approach. However, patients differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand the brain networks that mediate learned self-regulation with real-time fMRI. The objective of the present study is thus to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI. To achieve this goal, patients suffering from depression, post-traumatic stress disorder, and nicotine addiction will be trained to improve their self-regulation skills using established real-time fMRI neurofeedback protocols.
- Conditions
- Nicotine Dependence, Depression, PTSD
- Being tested
- Neurofeedback training, Sham Feedback
- Medical subject headings
- Tobacco Use Disorder, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback trainingOther
In a neurofeedback setting, brain activity is measured non-invasively, the brain imaging data is analyzed in real-time, and then feedback regarding the current level of brain activity is provided to the subject.
Sham FeedbackOther
Sham controlled neurofeedback training. Subjects in the sham control group will undergo the same procedure as subjects in the experimental group, but instead of being shown feedback derived from their own brain activity, they will be shown replayed feedback values from a randomly chosen subject of the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Neurofeedback training. Receives: Other: Neurofeedback training |
| Sham Feedback | Sham comparator | Sham controlled neurofeedback training. Subjects in the sham control group will undergo the same procedure as subjects in the experimental group, but instead of being shown feedback derived from their own brain activity, they will be shown replayed feedback values from a randomly chosen subject of the experimental group. Receives: Other: Sham Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain patterns that mediate learning self-regulation in patients with fMRI neurofeedback
Functional MRI data will be analysed using a whole brain mixed effect analysis across all subjects that compares brain patterns during self-regulation and baseline.
Measured: 12 months
Secondary outcomes (3)
neurofeedback learning success
Increased self-regulation skills will be assessed by a comparison of the slopes of the neurofeedback learning curves between subjects in the experimental group vs. the sham control group.
Measured: 12 months
behavioral consequences of neurofeedback training
Behavioral outcome measures (questionnaires, standard clinical assessments) will be compared between subjects in the experimental group vs. the sham control group.
Measured: 12 months
maintenance of learned self-regulation
An assessment of learned self-regulation (i.e. increase of the feedback signal in up-regulation compared to baseline blocks) in follow-up scanning sessions that will take place 6 months and 1 year after neurofeedback training. This will be a measure of how well learned self-regulation can be maintained.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 May 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frank Scharnowski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frank Scharnowski, Psychiatric University Hospital, Zurich
- Investigators
- Frank Scharnowski, Prof. Dr., Principal investigator, Hospital of Psychiatry, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165578
- Sponsor's protocol ID
- PsychiatricUHZ
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Neurofeedback Training
- ClinicalTrials.gov ID
- NCT03165578
- Acronym / sponsor ID
- PsychiatricUHZ
- Conditions
- Nicotine Dependence, Depression, PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Frank ScharnowskiUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present study is to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI.
Detailed description
Neurofeedback has been established as a promising non-pharmacological therapeutic approach. However, patients differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand the brain networks that mediate learned self-regulation with real-time fMRI. The objective of the present study is thus to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI. To achieve this goal, patients suffering from depression, post-traumatic stress disorder, and nicotine addiction will be trained to improve their self-regulation skills using established real-time fMRI neurofeedback protocols.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Other: Neurofeedback trainingNeurofeedback training. |
| Sham Feedback | Sham comparator | Other: Sham FeedbackSham controlled neurofeedback training. Subjects in the sham control group will undergo the same procedure as subjects in the experimental group, but instead of being shown feedback derived from their own brain activity, they will be shown replayed feedback values from a randomly chosen subject of the experimental group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Magnetic resonance imaging compatibility.
- DSM-V diagnosis of major depressive disorder, post-traumatic stress disorder, or nicotine addiction, respectively.
Key exclusion criteria (3 listed)
- Other physical or psychiatric disorders.
- Current substance abuse.
- Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback trainingIn a neurofeedback setting, brain activity is measured non-invasively, the brain imaging data is analyzed in real-time, and then feedback regarding the current level of brain activity is provided to the subject. | Other | Neurofeedback |
| Sham FeedbackSham controlled neurofeedback training. Subjects in the sham control group will undergo the same procedure as subjects in the experimental group, but instead of being shown feedback derived from their own brain activity, they will be shown replayed feedback values from a randomly chosen subject of the experimental group. | Other | Sham Feedback |
Primary outcome
brain patterns that mediate learning self-regulation in patients with fMRI neurofeedback
Time frame: 12 months
Functional MRI data will be analysed using a whole brain mixed effect analysis across all subjects that compares brain patterns during self-regulation and baseline.
3 secondary outcomes
neurofeedback learning success
Time frame: 12 months
behavioral consequences of neurofeedback training
Time frame: 12 months
maintenance of learned self-regulation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Scharnowski, Prof. Dr. principal investigator
Hospital of Psychiatry, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback training in people with Nicotine Dependence and Depression, run by Frank Scharnowski at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Scharnowski, Prof. Dr. (+41765682259, Frank.Scharnowski@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain patterns that mediate learning self-regulation in patients with fMRI neurofeedback (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.