Borderline Personality DisorderPhase 1/2BrainSTEADyNCT06626789
Brain Signal Training to Enhance Affect Down-regulation
A Phase 1/2 study testing Amygdala neurofeedback in people with Borderline Personality Disorder, run by Central Institute of Mental Health, Mannheim at 6 sites in Germany.
Trial summary
Individuals with Borderline Personality Disorder (BPD) experience intensive, instable negative emotions. Hyperactivity of the amygdala is assumed to drive exaggerated emotional responses in BPD. Neurofeedback is an endogenous neuromodulation method to address the imbalance of neural circuits. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Amygdala neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 6 sitesGermany
- Study dates
- 23 Apr 2025to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Treatment with benzodiazepines within 7 days prior the initial screening
- Current alcohol or substance dependence
- Meeting the diagnostic criteria for a psychotic disorder or schizophrenia (life-time), as determined by clinical interview at initial screening
- Current or history of significant neurological condition (such as stroke, traumatic brain injury, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack)
- Significant visual impairment that might interfere with the performance of the behavioural tasks or fMRI tasks
- Change of treatment (psychopharmacologic, psychological) 2 weeks prior to study participation or before completion of the post-assessment.
Show all 19Show fewer
- Treatment with any neurofeedback three months prior to or during the study participation.
- Unable or unwilling to comply with study procedures, including study prohibitions and restrictions
- History of claustrophobia or inability to tolerate scanner environment
- Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)
- Clinically relevant structural brain abnormality as determined by prior MRI scan
- Planned medical treatment within the study period that might interfere with the study procedures
- Participants deemed to be at significant risk of serious violence or suicide
- BMI of 16.5 or lower
- Participation in other clinical trials or observation period of competing trials, respectively
- Previous participation in this trial
- Pregnancy and lactation
- Held in an institution by legal or official order
- Legally incapacitated.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
University clinic Freiburg
Freiburg im Breisgau, 79104
Simon Maier, Dr., +49 (0) 761 65530, psy.brainsteady@uniklinik-freiburg.de
- Recruiting
University clinic Giessen
Giessen, 35392
Christian Schoenholz, Dr., +49 (0) 641 985 45702, Sekretariat-Mulert@psychiat.med.uni-giessen.de
- Not yet recruiting
University Clinic Halle (Saale)
Halle
Jana Weise, +49-345-557-3795, jana.weise@uk-halle.de
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
Gregor Leicht, +49-40-7410-59520, g.leicht@uke.de
- Recruiting
Central Institute of Mental Health
Mannheim, 68159
Christian Paret, Dr., +49 621 1703 ext. 4462, brainsteady-teilnehmen@zi-mannheim.de
Miroslava Jindrová, +49 621 1703 ext. 4463, brainsteady-teilnehmen@zi-mannheim.de
- Recruiting
University Clinic Tuebingen
Tübingen, 72076
Beatrix Barth, Dr., +49 (0) 761 65530, brainsteady@med.uni-tuebingen.de
About this study
Official title: A Multi-center, Patient-blinded and Investigator-blinded, Randomized, Parallel-group, Superiority Study to Compare the Efficacy of Four Sessions of Amygdala fMRI-BOLD Neurofeedback With Yoked Sham-control Neurofeedback in the Treatment of Dysregulated Affect in Borderline Personality Disorder
Individuals with Borderline Personality Disorder (BPD) experience intensive, instable negative emotions. Hyperactivity of the amygdala is assumed to drive exaggerated emotional responses in BPD. Neurofeedback is an endogenous neuromodulation method to address the imbalance of neural circuits. Downregulation of amygdala hyperactivation with neurofeedback may ameliorate dysregulated emotions in BPD. The BrainSTEADy trial is designed to determine whether amygdala-fMRI-BOLD neurofeedback has a specific effect on affect instability in BPD beyond nonspecific benefit.
Read the detailed description
Borderline Personality Disorder (BPD) is characterized by self-mutilation, suicidality, and severe interpersonal disturbances. These symptoms reflect pervasive emotion regulation problems. On the neural level, BPD patients show an inflated amygdala response to emotional cues. In addition, they have reduced neural control of the amygdala. The amygdala controls emotional experience and behavior. Therefore, current psychobiological theories consider amygdala hyper-activity a causal mechanism for emotional overreaction in BPD.
Functional magnetic resonance imaging (fMRI) allows the recording of activation in subcortical brain regions, such as the amygdala, in real time. Live feedback from brain activation (e.g. via a thermometer with the temperature reflecting the degree of activation) allows one to learn the voluntary control of the brain. Dubbed "neurofeedback" (NF), the method can result in long-lasting changes in neural activation patterns. NF allows precise targeting of dysfunctional neuro-circuitries that relate to clinical symptoms.
The project proposed here investigates the clinical effectivity of fMRI-based amygdala-NF training in BPD. In total, 164 patients will participate in four training sessions provided by four study centers: Tuebingen, Freiburg, Giessen, and Mannheim. The training aims to reduce affective instability in everyday life, which is assessed primarily by ambulatory assessment before and after treatment. During NF sessions, patients receive feedback from the BOLD (Blood Oxygenation Level Dependent) signal recorded in the amygdala while they view pictures with negative emotional content. The amygdala responds to these pictures with an activation increase. The patient observes the amygdala responding, illustrated via increased temperature in a thermometer beside the picture. The task is to decrease temperature. The procedure should teach patients to master overreaction at an early stage of neural emotion processing.
To assess the effectivity of amygdala-NF, a control group receives non-veridical feedback from a different patient. The investigators expect a significant reduction in affective instability with amygdala-NF. In addition, the investigators expect a greater reduction in affective instability in the amygdala-NF group versus the control group.
The trial will go through two stages of recruitment. Stage 1 is reached after recruitment of 82 participants. An interim analysis will be conducted. Depending on the results of the interim analysis, the trial will enter stage 2, ie. recruitment of the full number of planned participants.
Results from this study enable assessment of clinical efficacy of amygdala-NF. In the future, NF could serve as a precise tool for person-centered treatment of affective instability symptoms in mental disorders with severe emotion regulation problems such as BPD.
- Conditions
- Borderline Personality Disorder
- Being tested
- Amygdala neurofeedback, Sham neurofeedback
- Keywords
- Neurofeedback, fMRI, Neuroimaging, Amygdala, Affect instability, Emotion
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amygdala neurofeedbackBiological
Real-time fMRI neurofeedback from amygdala's blood oxygenation level dependent (BOLD) signal + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.
Sham neurofeedbackBehavioural
Recorded neurofeedback from a different participant + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Real-time functional Magnetic Resonance Imaging (fMRI) neurofeedback from the Blood Oxygenation Level Dependent (BOLD) signal of the amygdala Receives: Biological: Amygdala neurofeedback |
| Control group | Experimental | Feedback that is less correlated with amygdala BOLD signal Receives: Behavioral: Sham neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect Intensity, change from T0 to T1
Mean score of negative affect scale measured via experience sampling using ecological momentary assessment (EMA). Scale can take values from 1 to 7, high values mean higher affect intensity. EMA is conducted across 4 consecutive days, including a full weekend, when patients carry a smartphone that runs the EMA app. The app sends an auditory signal every hour, starting at 9 AM until 9 PM, to remind the patient to fill out the items.
Measured: Completion of T0 EMA sampling within 12 days before first NF session. Start of T1 EMA sampling within 1 week after last NF session.
Secondary outcomes (5)
Affect Intensity, change from T0 to T2
Mean score of negative affect scale measured via experience sampling using ecological momentary assessment (EMA). Scale can take values from 1 to 7, high values mean higher affect intensity. EMA is conducted across 4 consecutive days, including a full weekend, when patients carry a smartphone that runs the EMA app. The app sends an auditory signal every hour, starting at 9 AM until 9 PM, to remind the patient to fill out the items.
Measured: Completion of T0 EMA sampling within 12 days before first NF session. Start of T2 EMA sampling within 14-16 weeks after last NF session.
Borderline Symptom Severity, change from T0 to T1 and T0 to T2
Zanarini Rating Scale for BPD, interview version (ZAN-BPD) total score. Total score can take values 0-36 with higher values meaning higher symptom burden.
Measured: T0 assessed before first NF session (within 1-3 weeks). T1 assessed after last NF session (within 2-4 weeks). T2 assessed within 14-16 weeks after last NF session.
Amygdala response, change from T0 to T1.
BOLD-fMRI response in the amygdala to negative stimuli in the view-condition, during NF session 1, run 1, vs. last NF session, last run.
Measured: Time Frame: T0 assessed at Baseline. T1 assessed at Post-Assessment immediately after treatment.
Amygdala self-regulation, change from T0 to T1.
BOLD-fMRI response in the amygdala to negative stimuli in the regulate-condition, during NF session 1, run 1, vs. last NF session, last run.
Measured: Time Frame: T0 assessed at Baseline. T1 assessed at Post-Assessment immediately after treatment.
Improvement in quality-adjusted life years (QALY), change from T0 to T3
We measure health-related quality of life with the AQoL-6D (Centre for Health Economics, Monash University, 2016), a multi attribute utility instrument frequently used in health economic evaluations. We elicit quality adjusted life years (QALYs) from the AQoL-6D unweighted scorings by using established value sets. The derived QALYs range from 0.00 to 1.00, where 0.00 represents death and 1.00 a year in perfect health. We combine effects (QALYs) and costs of utilization between groups to receive incremental cost-effectiveness ratios (ICER). Thus, we are able to present costs per QALY for the neurofeedback intervention to inform stakeholders in health care about reimbursement decisions.
Measured: T0 assessed before first nf session (within 1-3 weeks). T3 assessed 6 months after last NF session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start23 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Freiburg, University of Giessen, University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Christian Paret-Voigt, Dr., Principal investigator, ZI Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626789
- Sponsor's protocol ID
- BrainSTEADy
- Acronym
- BrainSTEADy
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized and de-identified data will be uploaded to a data repository hosted by University of Heidelberg (heiDATA).
Publications
Zaehringer J, Ende G, Santangelo P, Kleindienst N, Ruf M, Bertsch K, Bohus M, Schmahl C, Paret C. Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder. Neuroimage Clin. 2019;24:102032. doi: 10.1016/j.nicl.2019.102032. Epub 2019 Oct 16.
PubMed 31795041Paret C, Kluetsch R, Zaehringer J, Ruf M, Demirakca T, Bohus M, Ende G, Schmahl C. Alterations of amygdala-prefrontal connectivity with real-time fMRI neurofeedback in BPD patients. Soc Cogn Affect Neurosci. 2016 Jun;11(6):952-60. doi: 10.1093/scan/nsw016. Epub 2016 Feb 1.
PubMed 26833918Paret C, Kluetsch R, Ruf M, Demirakca T, Hoesterey S, Ende G, Schmahl C. Down-regulation of amygdala activation with real-time fMRI neurofeedback in a healthy female sample. Front Behav Neurosci. 2014 Sep 18;8:299. doi: 10.3389/fnbeh.2014.00299. eCollection 2014.
PubMed 25278851Paret C, Jindrova M, Kleindienst N, Eck J, Breman H, Luhrs M, Barth B, Ethofer T, Fallgatter AJ, Goebel R, Hoell A, Lockhofen D, Reinhold AS, Maier S, Matthies S, Mulert C, Schonholz C, van Elst LT, Schmahl C. A randomised controlled trial of amygdala fMRI-neurofeedback versus sham-feedback in borderline-personality disorder - systematic literature review and introduction to the BrainSTEADy trial. BMC Psychiatry. 2025 Jul 8;25(1):687. doi: 10.1186/s12888-025-07000-1.
PubMed 40629288
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Patient-blinded and Investigator-blinded, Randomized, Parallel-group, Superiority Study to Compare the Efficacy of Four Sessions of Amygdala fMRI-BOLD Neurofeedback With Yoked Sham-control Neurofeedback in the Treatment of Dysregulated Affect in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT06626789
- Acronym / sponsor ID
- BrainSTEADy / BrainSTEADy
- Conditions
- Borderline Personality Disorder
- Keywords
- Neurofeedback, fMRI, Neuroimaging, Amygdala, Affect instability, Emotion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- University Medical Center Freiburg, University of Giessen, University Hospital Tuebingen
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Oct 2024 (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.
Individuals with Borderline Personality Disorder (BPD) experience intensive, instable negative emotions. Hyperactivity of the amygdala is assumed to drive exaggerated emotional responses in BPD. Neurofeedback is an endogenous neuromodulation method to address the imbalance of neural circuits. Downregulation of amygdala hyperactivation with neurofeedback may ameliorate dysregulated emotions in BPD. The BrainSTEADy trial is designed to determine whether amygdala-fMRI-BOLD neurofeedback has a specific effect on affect instability in BPD beyond nonspecific benefit.
Detailed description
Borderline Personality Disorder (BPD) is characterized by self-mutilation, suicidality, and severe interpersonal disturbances. These symptoms reflect pervasive emotion regulation problems. On the neural level, BPD patients show an inflated amygdala response to emotional cues. In addition, they have reduced neural control of the amygdala. The amygdala controls emotional experience and behavior. Therefore, current psychobiological theories consider amygdala hyper-activity a causal mechanism for emotional overreaction in BPD.
Functional magnetic resonance imaging (fMRI) allows the recording of activation in subcortical brain regions, such as the amygdala, in real time. Live feedback from brain activation (e.g. via a thermometer with the temperature reflecting the degree of activation) allows one to learn the voluntary control of the brain. Dubbed "neurofeedback" (NF), the method can result in long-lasting changes in neural activation patterns. NF allows precise targeting of dysfunctional neuro-circuitries that relate to clinical symptoms.
The project proposed here investigates the clinical effectivity of fMRI-based amygdala-NF training in BPD. In total, 164 patients will participate in four training sessions provided by four study centers: Tuebingen, Freiburg, Giessen, and Mannheim. The training aims to reduce affective instability in everyday life, which is assessed primarily by ambulatory assessment before and after treatment. During NF sessions, patients receive feedback from the BOLD (Blood Oxygenation Level Dependent) signal recorded in the amygdala while they view pictures with negative emotional content. The amygdala responds to these pictures with an activation increase. The patient observes the amygdala responding, illustrated via increased temperature in a thermometer beside the picture. The task is to decrease temperature. The procedure should teach patients to master overreaction at an early stage of neural emotion processing.
To assess the effectivity of amygdala-NF, a control group receives non-veridical feedback from a different patient. The investigators expect a significant reduction in affective instability with amygdala-NF. In addition, the investigators expect a greater reduction in affective instability in the amygdala-NF group versus the control group.
The trial will go through two stages of recruitment. Stage 1 is reached after recruitment of 82 participants. An interim analysis will be conducted. Depending on the results of the interim analysis, the trial will enter stage 2, ie. recruitment of the full number of planned participants.
Results from this study enable assessment of clinical efficacy of amygdala-NF. In the future, NF could serve as a precise tool for person-centered treatment of affective instability symptoms in mental disorders with severe emotion regulation problems such as BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: Amygdala neurofeedbackReal-time functional Magnetic Resonance Imaging (fMRI) neurofeedback from the Blood Oxygenation Level Dependent (BOLD) signal of the amygdala |
| Control group | Experimental | Behavioral: Sham neurofeedbackFeedback that is less correlated with amygdala BOLD signal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Treatment with benzodiazepines within 7 days prior the initial screening
- Current alcohol or substance dependence
- Meeting the diagnostic criteria for a psychotic disorder or schizophrenia (life-time), as determined by clinical interview at initial screening
- Current or history of significant neurological condition (such as stroke, traumatic brain injury, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack)
- Significant visual impairment that might interfere with the performance of the behavioural tasks or fMRI tasks
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 |
|---|---|---|
| Amygdala neurofeedbackReal-time fMRI neurofeedback from amygdala's blood oxygenation level dependent (BOLD) signal + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response. | Biological | Intervention group |
| Sham neurofeedbackRecorded neurofeedback from a different participant + negative emotional picture viewing. Instruction to regulate feedback via down-regulation of one's emotional response. | Behavioural | Control group |
Primary outcome
Affect Intensity, change from T0 to T1
Time frame: Completion of T0 EMA sampling within 12 days before first NF session. Start of T1 EMA sampling within 1 week after last NF session.
Mean score of negative affect scale measured via experience sampling using ecological momentary assessment (EMA). Scale can take values from 1 to 7, high values mean higher affect intensity. EMA is conducted across 4 consecutive days, including a full weekend, when patients carry a smartphone that runs the EMA app. The app sends an auditory signal every hour, starting at 9 AM until 9 PM, to remind the patient to fill out the items.
5 secondary outcomes
Affect Intensity, change from T0 to T2
Time frame: Completion of T0 EMA sampling within 12 days before first NF session. Start of T2 EMA sampling within 14-16 weeks after last NF session.
Borderline Symptom Severity, change from T0 to T1 and T0 to T2
Time frame: T0 assessed before first NF session (within 1-3 weeks). T1 assessed after last NF session (within 2-4 weeks). T2 assessed within 14-16 weeks after last NF session.
Amygdala response, change from T0 to T1.
Time frame: Time Frame: T0 assessed at Baseline. T1 assessed at Post-Assessment immediately after treatment.
Amygdala self-regulation, change from T0 to T1.
Time frame: Time Frame: T0 assessed at Baseline. T1 assessed at Post-Assessment immediately after treatment.
Improvement in quality-adjusted life years (QALY), change from T0 to T3
Time frame: T0 assessed before first nf session (within 1-3 weeks). T3 assessed 6 months after last NF session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 31795041Zaehringer J, Ende G, Santangelo P, Kleindienst N, Ruf M, Bertsch K, Bohus M, Schmahl C, Paret C. Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder. Neuroimage Clin. 2019;24:102032. doi: 10.1016/j.nicl.2019.102032. Epub 2019 Oct 16.
- Background: PubMed 26833918Paret C, Kluetsch R, Zaehringer J, Ruf M, Demirakca T, Bohus M, Ende G, Schmahl C. Alterations of amygdala-prefrontal connectivity with real-time fMRI neurofeedback in BPD patients. Soc Cogn Affect Neurosci. 2016 Jun;11(6):952-60. doi: 10.1093/scan/nsw016. Epub 2016 Feb 1.
- Background: PubMed 25278851Paret C, Kluetsch R, Ruf M, Demirakca T, Hoesterey S, Ende G, Schmahl C. Down-regulation of amygdala activation with real-time fMRI neurofeedback in a healthy female sample. Front Behav Neurosci. 2014 Sep 18;8:299. doi: 10.3389/fnbeh.2014.00299. eCollection 2014.
- Derived from this study: PubMed 40629288Paret C, Jindrova M, Kleindienst N, Eck J, Breman H, Luhrs M, Barth B, Ethofer T, Fallgatter AJ, Goebel R, Hoell A, Lockhofen D, Reinhold AS, Maier S, Matthies S, Mulert C, Schonholz C, van Elst LT, Schmahl C. A randomised controlled trial of amygdala fMRI-neurofeedback versus sham-feedback in borderline-personality disorder - systematic literature review and introduction to the BrainSTEADy trial. BMC Psychiatry. 2025 Jul 8;25(1):687. doi: 10.1186/s12888-025-07000-1.
- Trial recruitment websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pseudonymized and de-identified data will be uploaded to a data repository hosted by University of Heidelberg (heiDATA).
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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.
Christian Paret-Voigt, Dr. principal investigator
ZI Mannheim
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amygdala neurofeedback in people with Borderline Personality Disorder, run by Central Institute of Mental Health, Mannheim at 6 sites in Germany.
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 0 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Paret-Voigt, Dr. (+4962117034462, christian.paret@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affect Intensity, change from T0 to T1 (time frame: Completion of T0 EMA sampling within 12 days before first NF session. Start of T1 EMA sampling within 1 week after last NF session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06626789, which also lists 4 linked publications.
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 17 Aug 2026.