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Protocol Details

Neural and Psychological Mechanisms of Pain Perception

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-AT-0132

Sponsoring Institute

National Center for Complementary and Integrative Health (NCCIH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 50 Years

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking

Keywords

Pain;
Visual Analogue Pain Scale;
Placebo;
Affective Neuroscience;
Functional Magnetic Resonance Imaging (fMRI)

Recruitment Keyword(s)

None

Condition(s)

Pain;
Normal Physiology;
Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Instructions
Behavioral: Attention
Behavioral: Thermal Pain
Behavioral: Placebo instructions

Supporting Site

National Center for Complementary and Integrative Health

Background:

- Painful stimuli cause changes in a network of brain regions called the "Pain Matrix." But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision.

Objectives:

- To better understand how pain and emotions are processed and influenced by psychological factors.

Eligibility:

- Healthy volunteers ages 18-50.

Design:

- This study requires 1 to 2 clinic visits that last 1 to 3 hours.

- Participants will be screened with medical history and physical exam.

- Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs.

- Participants heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored.

- Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI.

- Participants will fill out questionnaires.

- The study will last 3 years.

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Eligibility

INCLUSION CRITERIA:

-Healthy

-Between 18 and 50 years old

-Fluent in English

-Able to provide written informed consent.

EXCLUSION CRITERIA (all sub-studies):

-Unable to comply with study procedures or follow-up visits.

-Has a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, neurological or psychiatric conditions (including stroke and blindness or deafness, a history of brain damage, substance or alcohol dependence or abuse or psychosis) or a chronic systemic disease (e.g., diabetes).

-Has a medical condition that in a clinician's assessment might affect somatosensation (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder).

-Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).

-Has a dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous 4 weeks that might influence cutaneous sensibility.

-Regular use of prescription medication that has a significant effect on pain or heat perception. Excluded medications include central-acting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbituates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an "as needed" basis is acceptable as long as the last dose taken was within 5 half-lives of testing.

-Is pregnant.

-NCCIH and NIMH employees.

EXCLUSION CRITERIA (fMRI sub-studies):

-Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure or pain stimulation will be excluded from the MRI portion of the protocol, but may participate in the non-fMRI sessions (with the exception of pregnant women). Such conditions include:

--Those with ferromagnetic metal in the cranial cavity or eye, e.g.. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.

--Those with an abnormality on a structural MRI.

--Those with an implanted cardiac pacemaker or auto-defibrillator.

--Those with an insulin pump.

--Those with an irremovable body piercing.

--Pregnant women (based on urine test completed within 24 hours prior to scan).

-Individuals who are left-handed (based on self-report or score on handedness questionnaire) will be excluded from fMRI substudies.

EXCLUSION CRITERIA (placebo analgesia sub-studies):

-Participation in an NIH study of analgesia, as gleaned from CRIS


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lauren Y. Atlas, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health
Building 10
Room 4-1741
10 Center Drive
Bethesda, Maryland 20892
(301) 827-0214
lauren.atlas@nih.gov

Adebisi O. Ayodele, C.R.N.P.
National Center for Complementary and Integrative Health (NCCIH)
NIHBC 10 - CLINICAL CENTER BG RM 2A21
10 CENTER DR
BETHESDA MD 20892
(240) 593-4226
bisi.ayodele@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02446262

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