Human Behaviors Related to the Expectation of Pain (NCT03739645) | Clinical Trial Compass
TerminatedNot Applicable
Human Behaviors Related to the Expectation of Pain
Stopped: Lack of Funding
United States32 participantsStarted 2020-08-01
Plain-language 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. .
Who can participate
Age range
16 Years – 88 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Skin Conductance Response
Timeframe: 5 seconds post conditioned stimulus
2
State Anxiety as Assessed by the Spielberger State-Trait Anxiety Inventory
Timeframe: Baseline, post conditioning up to 6 minutes
3
Experimental Pain as Assessed by a Pain Rating Scale
Timeframe: Post conditioning approximately 6 minutes