Human Behaviors Related to the Expectation of Pain

NCT03739645 | Terminated Results

• 2 other identifiers: NA_000799322R56NS038493-16A1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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. .

Conditions

Fear Pain

Keywords

fear; pain; conditioning; skin conductance response; Ratings of Pain and Conditioning; Eye position metrics

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Post conditioning approximately 6 minutes

Study Arms (1)

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

Behavioral: Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety

Interventions

Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety BEHAVIORAL

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.

Eye position and tense arousal over time a metrics for sustained attention in conditioned fear.

Eligibility Criteria

• Age: 16 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Maryland: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Hopkins Epilepsy Monitoring Unit, Zayhed 12.

Baltimore, Maryland, 21287-7713, United States

Location

Related Publications (5)

• 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.

  PMID: 21256929 RESULT

• Liu 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.

  PMID: 26168707 RESULT

• Chien 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.

  PMID: 28077278 RESULT

• Liu 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.

  PMID: 21664438 RESULT

• Liu 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.

  PMID: 19925853 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Fred Lenz
• Organization: Johns Hopkins University

flenz1@jhmi.edu

443.287.1609

Study Officials

• Fred A Lenz, MD PhD

  Dept of Neurosurgery, Hopkins University.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 14, 2018
• Study Start: August 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The website will be complete in 3 years.

Locations

US (1)