Fear PainNCT03739645
Human Behaviors Related to the Expectation of Pain
A study testing Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety in people with Fear Pain, run by Johns Hopkins University at 1 site in United States.
Trial summary
The conditioned expectation of pain is an important aspect of pain-related disability produced by environments and stimuli associated with a painful injury on the job, although the neuroscience of this expectation is unclear. Read more about this study
- Who is it for?
- Ages 16 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear Pain
- What is being tested?
- Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 88 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Man or woman between 18 and 80 years of age.
- Fluent speaker of English.
- Undergoing seizure monitoring at Hopkins Hospital through intracranial electrodes.
- Possess ability to understand study procedures and comply with them for the entire length of the study;
- Women of childbearing age must use pharmacological contraception (oral or patch) for the duration of the study follow-up.
Who cannot join
- Inability or unwillingness of individual to give written informed consent. Presence of any neurological disease other than epilepsy which is unstable or is not optimally treated.
- Presence of a significant abnormality on routine neuropsychological testing.
- Presence of any medical or psychiatric disease which is unstable or is not optimally treated.
- Presence of an abnormal MRI scan except for Normal variants or Medial Temporal Sclerosis (altered pathology and MRI signal in temporal lobe).
- Women who are pregnant or women of childbearing capacity who may become pregnant (i.e. not using contraception).
- Presence of generalized seizures, or reflex seizures i.e. triggered by a sensory stimulus.
- Presence of a language or hearing impairment.
- Non-English speakers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hopkins Epilepsy Monitoring Unit, Zayhed 12.
Baltimore, Maryland, 21287-7713
About this study
Official title: Physiological Studies in Healthy Subjects, Chronic Pain Patients and in Patients Undergoing Neurosurgical Procedures of Human Forebrain Mechanisms Mediating Somatic Sensation, Motor Control and Neurological Disorders
The conditioned expectation of pain is an important aspect of pain-related disability produced by environments and stimuli associated with a painful injury on the job, although the neuroscience of this expectation is unclear. We will develop and use novel objective methods for measurement of expectation and threat related attention. The results of this study may lead to testable hypotheses regarding the psychological basis of the fear of pain, threat and task related attention. We will also use these results, and development of novel autonomic and ratings metrics for state and trait anxiety as well as threat and task related attention which could be used as an instrumented test for diagnosis and management of PTSD and anxiety disorders. .
Read the detailed description
The conditioned expectation or fear of pain often results in disability produced by stimuli related to a painful injury on the job, although there are questions about attentional and anxiety related expectation. Conditioned expectation in humans can be produced by a protocol that consists of a train of two visual conditioning stimuli, one of which is paired (CS+) with a painful laser pulse unconditioned stimulus (US), while the other is not. This protocol will be used to study the expectation of pain in this study, and its relationship to task and threat related attention measured by eye position and to anxiety, task directed sustained attention, and scalp EEG metrics. These results may also be used in an instrumented test for the diagnosis and management of PTSD and anxiety disorders.
EEG studies may clarify the relationship of unpleasantness (valence) and the ability of stimuli to command attention (salience) of the conditioned and unconditioned stimuli which which are significant but under studied aspects of the fear of the pain. Studies of scalp EEG activation and functional connectivity will be used to estimate global properties of the forebrain networks involved in the fear of pain, as well as the valence and the salience) of the conditioned and unconditioned stimuli.
Activations are measured by the proportion of electrodes over a quadrant or lobe of the scalp a significant ratio of electrical power following an event over baseline (event related spectral perturbation, ERSP). Functional connectivity will be measured by causal interactions following an event over baseline. The approach of this protocol is that causal interactions are based upon causal influences by an approach based upon the concept of linear predictability. Briefly, a signal Y is said to exert an influence upon signal X when the predication error of the X is reduced by adding the past information of Y (causal interaction). The signals from any two quadrants or lobes will be analyzed by event related causality to determine the magnitude and direction of causal interactions between the two to determine fear and pain related directed interactions related to aversive conditioning.
Our Preliminary Data shows EEG activations in global distributed forebrain networks for the expectation of pain are consistent with the evidence of studies of anatomic projections and functional MRI (fMRI) signals. These models including our Preliminary Data from intracranial recordings identify structures in the medial temporal lobe (amygdala and hippocampus) which are involved in expectation of pain, while EEG suggests global activations related to valence and salience of conditioned and unconditioned stimuli. The premise of this study is that novel autonomic and eye position metrics will measure state and trait anxiety as well as threat and task related attention to parse out the experience and anticipation of pain.
- Conditions
- Fear Pain
- Being tested
- Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety
- Keywords
- fear, pain, conditioning, skin conductance response, Ratings of Pain and Conditioning, Eye position metrics
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxietyBehavioural
After fear conditioning the cue induces autonomic responses like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after cueing or conditioning. Activity across blocks in the conditioning stage shows that the skin conductance can be described by levels, and slopes which might be related to state anxiety and trait anxiety (Spielberger trait and state anxiety inventory or questionnaire). These skin conductance measures may be concrete metrics for psychological processes in healthy subjects. We will carry out a partial correlation analysis of levels, state anxiety and trait anxiety, and then a similar analysis of slopes, state anxiety and trait anxiety. These results may show that concrete skin conductance levels and slopes are related to metrics of subjective self report measures of state and trait anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Eye position and tense arousal over time a metrics for sustained attention in conditioned fear. | Experimental | After conditioning the conditioned stimulus induces autonomic metrics like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after conditioning. Activity across blocks in the conditioning stage demonstrates that the skin conductance can produce a progressive decrease in skin conductance over the conditioning stage of our fear conditioning protocol. The decline is not apparently related to habituation or changes in the skin conducting electrodes or recording system. It does correspond to the decrease in performance of a visual fixation task which is part of the fear conditioning during the conditioning stage; and to an increase in the unpleasant psychologic activation termed tense arousal over the same stage. If both these changes are found he then we may conclude that sustained task related attention is produced during fear conditioning Receives: Behavioral: Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Conductance Response
Concrete metric is skin conductance response to painful laser pulse stimulus measured in microSiemens. Higher values mean more emotional arousal or stress. All participants experienced two types of conditioned stimuli, one stimulus signaled danger and the other safety. Only during the danger stimulus would the participant receive a laser pulse.
Measured: 5 seconds post conditioned stimulus
State Anxiety as Assessed by the Spielberger State-Trait Anxiety Inventory
The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report questionnaire with 20 items designed to assess State anxiety (temporary feelings of anxiety). The State anxiety score range is between 20 and 80 with higher scores representing higher anxiety. State anxiety was measured and is reported.
Measured: Baseline, post conditioning up to 6 minutes
Experimental Pain as Assessed by a Pain Rating Scale
Pain Rating for Unpleasantness on a scale of 0 - 10 where 10 is the worst imaginable. All participants experienced two types of conditioned stimuli, one stimulus signaled danger and the other safety. Only during the danger stimulus would the participant receive a laser pulse.
Measured: Post conditioning approximately 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Aug 2020
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fear PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Analysis of eye position and skin conductance levels will be examined to identify attentional and anxiety related processes for the fear of pain during the conditioned stage. Correlation of skin conductance levels versus slopes during the conditioning stage with state versus trait anxiety will be taken as confirmatory evidence. Power analysis for a two-way ANOVA was conducted to determine a sufficient sample size using an alpha of 0.05, power 0.80, a high effect size (pilot data indicate η2 values for main effects \> 0.5). Based on these assumptions, we conservatively use a sample size of 40.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Fred A Lenz, MD PhD, Principal investigator, Dept of Neurosurgery, Hopkins University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739645
- Sponsor's protocol ID
- NA_00079932
- Other IDs
- 2R56NS038493-16A1
- Status last verified
- May 2025
- First submitted
- 2 Nov 2018
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI and Co-PIs are working with the Johns Hopkins Pain Research Institute to set up a website for the Institute to include the labs carrying out pain research in the Department of neurosurgery. As a part of this effort we will include the Functional Neurosurgery Lab to share the following information in the public domain: 1. Our research focus. 2. Biosketches of the investigators 3. All publications as final manuscripts at the time of acceptance for publication, 4. Funded grant applications 5. Collaborators 6. Contact information.
Publications
Liu CC, Shi CQ, Franaszczuk PJ, Crone NE, Schretlen D, Ohara S, Lenz FA. Painful laser stimuli induce directed functional interactions within and between the human amygdala and hippocampus. Neuroscience. 2011 Mar 31;178:208-17. doi: 10.1016/j.neuroscience.2011.01.029. Epub 2011 Jan 20.
PubMed 21256929Liu CC, Chien JH, Kim JH, Chuang YF, Cheng DT, Anderson WS, Lenz FA. Cross-frequency coupling in deep brain structures upon processing the painful sensory inputs. Neuroscience. 2015 Sep 10;303:412-21. doi: 10.1016/j.neuroscience.2015.07.010. Epub 2015 Jul 10.
PubMed 26168707Chien JH, Colloca L, Korzeniewska A, Cheng JJ, Campbell CM, Hillis AE, Lenz FA. Oscillatory EEG activity induced by conditioning stimuli during fear conditioning reflects Salience and Valence of these stimuli more than Expectancy. Neuroscience. 2017 Mar 27;346:81-93. doi: 10.1016/j.neuroscience.2016.12.047. Epub 2017 Jan 8.
PubMed 28077278Liu CC, Crone NE, Franaszczuk PJ, Cheng DT, Schretlen DS, Lenz FA. Fear conditioning is associated with dynamic directed functional interactions between and within the human amygdala, hippocampus, and frontal lobe. Neuroscience. 2011 Aug 25;189:359-69. doi: 10.1016/j.neuroscience.2011.05.067. Epub 2011 Jun 12.
PubMed 21664438Liu CC, Ohara S, Franaszczuk P, Zagzoog N, Gallagher M, Lenz FA. Painful stimuli evoke potentials recorded from the medial temporal lobe in humans. Neuroscience. 2010 Feb 17;165(4):1402-11. doi: 10.1016/j.neuroscience.2009.11.026. Epub 2009 Nov 17.
PubMed 19925853
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Studies in Healthy Subjects, Chronic Pain Patients and in Patients Undergoing Neurosurgical Procedures of Human Forebrain Mechanisms Mediating Somatic Sensation, Motor Control and Neurological Disorders
- ClinicalTrials.gov ID
- NCT03739645
- Acronym / sponsor ID
- NA_00079932
- Conditions
- Fear Pain
- Keywords
- fear, pain, conditioning, skin conductance response, Ratings of Pain and Conditioning, Eye position metrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Funding
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The conditioned expectation of pain is an important aspect of pain-related disability produced by environments and stimuli associated with a painful injury on the job, although the neuroscience of this expectation is unclear. We will develop and use novel objective methods for measurement of expectation and threat related attention. The results of this study may lead to testable hypotheses regarding the psychological basis of the fear of pain, threat and task related attention. We will also use these results, and development of novel autonomic and ratings metrics for state and trait anxiety as well as threat and task related attention which could be used as an instrumented test for diagnosis and management of PTSD and anxiety disorders. .
Detailed description
The conditioned expectation or fear of pain often results in disability produced by stimuli related to a painful injury on the job, although there are questions about attentional and anxiety related expectation. Conditioned expectation in humans can be produced by a protocol that consists of a train of two visual conditioning stimuli, one of which is paired (CS+) with a painful laser pulse unconditioned stimulus (US), while the other is not. This protocol will be used to study the expectation of pain in this study, and its relationship to task and threat related attention measured by eye position and to anxiety, task directed sustained attention, and scalp EEG metrics. These results may also be used in an instrumented test for the diagnosis and management of PTSD and anxiety disorders.
EEG studies may clarify the relationship of unpleasantness (valence) and the ability of stimuli to command attention (salience) of the conditioned and unconditioned stimuli which which are significant but under studied aspects of the fear of the pain. Studies of scalp EEG activation and functional connectivity will be used to estimate global properties of the forebrain networks involved in the fear of pain, as well as the valence and the salience) of the conditioned and unconditioned stimuli.
Activations are measured by the proportion of electrodes over a quadrant or lobe of the scalp a significant ratio of electrical power following an event over baseline (event related spectral perturbation, ERSP). Functional connectivity will be measured by causal interactions following an event over baseline. The approach of this protocol is that causal interactions are based upon causal influences by an approach based upon the concept of linear predictability. Briefly, a signal Y is said to exert an influence upon signal X when the predication error of the X is reduced by adding the past information of Y (causal interaction). The signals from any two quadrants or lobes will be analyzed by event related causality to determine the magnitude and direction of causal interactions between the two to determine fear and pain related directed interactions related to aversive conditioning.
Our Preliminary Data shows EEG activations in global distributed forebrain networks for the expectation of pain are consistent with the evidence of studies of anatomic projections and functional MRI (fMRI) signals. These models including our Preliminary Data from intracranial recordings identify structures in the medial temporal lobe (amygdala and hippocampus) which are involved in expectation of pain, while EEG suggests global activations related to valence and salience of conditioned and unconditioned stimuli. The premise of this study is that novel autonomic and eye position metrics will measure state and trait anxiety as well as threat and task related attention to parse out the experience and anticipation of pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Analysis of eye position and skin conductance levels will be examined to identify attentional and anxiety related processes for the fear of pain during the conditioned stage. Correlation of skin conductance levels versus slopes during the conditioning stage with state versus trait anxiety will be taken as confirmatory evidence. Power analysis for a two-way ANOVA was conducted to determine a sufficient sample size using an alpha of 0.05, power 0.80, a high effect size (pilot data indicate η2 values for main effects > 0.5). Based on these assumptions, we conservatively use a sample size of 40.
| Arm | Type | Receives |
|---|---|---|
| Eye position and tense arousal over time a metrics for sustained attention in conditioned fear. | Experimental | Behavioral: Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxietyAfter conditioning the conditioned stimulus induces autonomic metrics like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after conditioning. Activity across blocks in the conditioning stage demonstrates that the skin conductance can produce a progressive decrease in skin conductance over the conditioning stage of our fear conditioning protocol. The decline is not apparently related to habituation or changes in the skin conducting electrodes or recording system. It does correspond to the decrease in performance of a visual fixation task which is part of the fear conditioning during the conditioning stage; and to an increase in the unpleasant psychologic activation termed tense arousal over the same stage. If both these changes are found he then we may conclude that sustained task related attention is produced during fear conditioning |
Who may qualify
- Ages
- 16 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman between 18 and 80 years of age.
- Fluent speaker of English.
- Undergoing seizure monitoring at Hopkins Hospital through intracranial electrodes.
- Possess ability to understand study procedures and comply with them for the entire length of the study;
- Women of childbearing age must use pharmacological contraception (oral or patch) for the duration of the study follow-up.
Key exclusion criteria (8 listed)
- Inability or unwillingness of individual to give written informed consent. Presence of any neurological disease other than epilepsy which is unstable or is not optimally treated.
- Presence of a significant abnormality on routine neuropsychological testing.
- Presence of any medical or psychiatric disease which is unstable or is not optimally treated.
- Presence of an abnormal MRI scan except for Normal variants or Medial Temporal Sclerosis (altered pathology and MRI signal in temporal lobe).
- Women who are pregnant or women of childbearing capacity who may become pregnant (i.e. not using contraception).
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 |
|---|---|---|
| Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxietyAfter fear conditioning the cue induces autonomic responses like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after cueing or conditioning. Activity across blocks in the conditioning stage shows that the skin conductance can be described by levels, and slopes which might be related to state anxiety and trait anxiety (Spielberger trait and state anxiety inventory or questionnaire). These skin conductance measures may be concrete metrics for psychological processes in healthy subjects. We will carry out a partial correlation analysis of levels, state anxiety and trait anxiety, and then a similar analysis of slopes, state anxiety and trait anxiety. These results may show that concrete skin conductance levels and slopes are related to metrics of subjective self report measures of state and trait anxiety. | Behavioural | Eye position and tense arousal over time a metrics for sustained attention in conditioned fear. |
Primary outcome
Skin Conductance Response
Time frame: 5 seconds post conditioned stimulus
Concrete metric is skin conductance response to painful laser pulse stimulus measured in microSiemens. Higher values mean more emotional arousal or stress. All participants experienced two types of conditioned stimuli, one stimulus signaled danger and the other safety. Only during the danger stimulus would the participant receive a laser pulse.
State Anxiety as Assessed by the Spielberger State-Trait Anxiety Inventory
Time frame: Baseline, post conditioning up to 6 minutes
The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report questionnaire with 20 items designed to assess State anxiety (temporary feelings of anxiety). The State anxiety score range is between 20 and 80 with higher scores representing higher anxiety. State anxiety was measured and is reported.
Experimental Pain as Assessed by a Pain Rating Scale
Time frame: Post conditioning approximately 6 minutes
Pain Rating for Unpleasantness on a scale of 0 - 10 where 10 is the worst imaginable. All participants experienced two types of conditioned stimuli, one stimulus signaled danger and the other safety. Only during the danger stimulus would the participant receive a laser pulse.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21256929Liu CC, Shi CQ, Franaszczuk PJ, Crone NE, Schretlen D, Ohara S, Lenz FA. Painful laser stimuli induce directed functional interactions within and between the human amygdala and hippocampus. Neuroscience. 2011 Mar 31;178:208-17. doi: 10.1016/j.neuroscience.2011.01.029. Epub 2011 Jan 20.
- Results publication: PubMed 26168707Liu CC, Chien JH, Kim JH, Chuang YF, Cheng DT, Anderson WS, Lenz FA. Cross-frequency coupling in deep brain structures upon processing the painful sensory inputs. Neuroscience. 2015 Sep 10;303:412-21. doi: 10.1016/j.neuroscience.2015.07.010. Epub 2015 Jul 10.
- Results publication: PubMed 28077278Chien JH, Colloca L, Korzeniewska A, Cheng JJ, Campbell CM, Hillis AE, Lenz FA. Oscillatory EEG activity induced by conditioning stimuli during fear conditioning reflects Salience and Valence of these stimuli more than Expectancy. Neuroscience. 2017 Mar 27;346:81-93. doi: 10.1016/j.neuroscience.2016.12.047. Epub 2017 Jan 8.
- Results publication: PubMed 21664438Liu CC, Crone NE, Franaszczuk PJ, Cheng DT, Schretlen DS, Lenz FA. Fear conditioning is associated with dynamic directed functional interactions between and within the human amygdala, hippocampus, and frontal lobe. Neuroscience. 2011 Aug 25;189:359-69. doi: 10.1016/j.neuroscience.2011.05.067. Epub 2011 Jun 12.
- Results publication: PubMed 19925853Liu CC, Ohara S, Franaszczuk P, Zagzoog N, Gallagher M, Lenz FA. Painful stimuli evoke potentials recorded from the medial temporal lobe in humans. Neuroscience. 2010 Feb 17;165(4):1402-11. doi: 10.1016/j.neuroscience.2009.11.026. Epub 2009 Nov 17.
- Individual participant dataSharing planned: Yes. The PI and Co-PIs are working with the Johns Hopkins Pain Research Institute to set up a website for the Institute to include the labs carrying out pain research in the Department of neurosurgery. As a part of this effort we will include the Functional Neurosurgery Lab to share the following information in the public domain: 1. Our research focus. 2. Biosketches of the investigators 3. All publications as final manuscripts at the time of acceptance for publication, 4. Funded grant applications 5. Collaborators 6. Contact information.
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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.
Fred A Lenz, MD PhD principal investigator
Dept of Neurosurgery, Hopkins University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety in people with Fear Pain, run by Johns Hopkins University at 1 site in United States.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 May 2025. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Conductance Response (time frame: 5 seconds post conditioned stimulus). The study lists 3 primary outcomes in all. 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 NCT03739645, which also lists 5 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 25 May 2025.