RECRUITING

Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort

Conditions

Fatigue Syndrome, Chronic Punishment Pain Physical Exertion Effort Brain Magnetic Resonance Imaging Neuroimaging Psychophysics Reward

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: The way the brain processes rewards and punishments may play a role in some disorders of the nervous system. People with chronic overlapping pain conditions (such as myalgic encephalomyelitis/chronic fatigue syndrome \[ME/CFS\]) may have heightened responses to unpleasant, punishing sensations. Some of these conditions may also cause heightened responses to effort; this is an unpleasant sensation felt during physical and mental exertion. Objective: To learn more about how the brain processes different unpleasant sensations. Eligibility: People aged 18 to 50 years with ME/CFS. Healthy volunteers are also needed. Design: Participants will have 3 visits in 1 to 5 weeks. Visit 1: Participants may have a neurologic exam. They will have a mock magnetic resonance imaging (MRI) scan. They will lie on a bed in a wooden tube while they practice 2 tasks: Thermal pain rating: A device that creates mild to moderate heat will be placed on one leg. Physical effort rating: Participants will squeeze a plastic bar with different levels of force. Visit 2: Participants will have a real MRI scan. They will lie on a table that slides into a large tube. Visit 3: Participants will have another MRI scan. They will repeat the thermal pain and physical effort tasks while in the scanner. Sensors will be placed on 1 arm to measure how the muscles function as they squeeze the bar. Their heart rate will be tested: They will hold their finger against a camera lens for 1 minute. They will do 2 other tasks: 1 requires repeatedly pressing a key on a keyboard, and the other requires squeezing a bar.

Official Title

Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort

Quick Facts

Study Start:2025-01-01

Study Completion:2034-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06472622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 18-50 (inclusive). 4. Good general health as evidenced by medical history and/or physical examination. 1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 18-50 (inclusive). 4. Has a diagnosis of ME/CFS, meeting at least one of three ME/CFS criteria: the 1994 Fukuda Criteria, the 2003 Canadian Consensus Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, or the Institute of Medicine Diagnostic Criteria.	1. Any current major neurological or psychiatric disorder such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder. 2. Any other current major medical disorder, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively affect the individual s ability to cooperate with study procedures. 3. Current use of medications acting primarily on the central nervous system, such as antidepressants, stimulants, etc. 4. Use of opioid medications for more than two weeks within the last two years or any use in the last month. 5. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week). 6. Any more than occasional use of cannabis, defined as a score \>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire. 7. Any use of other illicit drugs or misuse of prescription medications, defined as a score \>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire. 8. Condition or injury affecting grip. 9. Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated. 10. Contraindications to MRI, including ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body, implanted cardiac pacemaker, auto-defibrillator, or pump, non-removable body piercing, claustrophobia, inability to lie supine for 90 minutes, pregnancy, or plans to become pregnant during the study. 11. Members of the NINDS BNU and their family members. 1. Any current major neurological or psychiatric disorder, other than ME/CFS, such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder. 2. Any other current major medical disorder, other than ME/CFS, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively 3. Current use of psychomotor stimulants, antipsychotics, or benzodiazepines. 4. Use of opioid medications for more than two weeks within the last two years or any use in the last month. 5. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week). 6. Any more than occasional use of cannabis, defined as a score \>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire. 7. Any use of other illicit drugs or misuse of prescription medications, defined as a score \>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire. 8. Condition or injury affecting grip. 9. Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated. 10. Contraindications to MRI, including ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body, implanted cardiac pacemaker, auto-defibrillator, or pump, non-removable body piercing, claustrophobia, inability to lie supine for 90 minutes, pregnancy, or plans to become pregnant during the study. 11. Members of the NINDS BNU and their family members.

Inclusion Criteria

Exclusion Criteria

1. Ability of subject to understand and the willingness to sign a written informed consent document.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18-50 (inclusive).
4. Good general health as evidenced by medical history and/or physical examination.
1. Ability of subject to understand and the willingness to sign a written informed consent document.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18-50 (inclusive).
4. Has a diagnosis of ME/CFS, meeting at least one of three ME/CFS criteria: the 1994 Fukuda Criteria, the 2003 Canadian Consensus Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, or the Institute of Medicine Diagnostic Criteria.

1. Any current major neurological or psychiatric disorder such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder.
2. Any other current major medical disorder, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively affect the individual s ability to cooperate with study procedures.
3. Current use of medications acting primarily on the central nervous system, such as antidepressants, stimulants, etc.
4. Use of opioid medications for more than two weeks within the last two years or any use in the last month.
5. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week).
6. Any more than occasional use of cannabis, defined as a score \>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire.
7. Any use of other illicit drugs or misuse of prescription medications, defined as a score \>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire.
8. Condition or injury affecting grip.
9. Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated.
10. Contraindications to MRI, including ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body, implanted cardiac pacemaker, auto-defibrillator, or pump, non-removable body piercing, claustrophobia, inability to lie supine for 90 minutes, pregnancy, or plans to become pregnant during the study.
11. Members of the NINDS BNU and their family members.
1. Any current major neurological or psychiatric disorder, other than ME/CFS, such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder.
2. Any other current major medical disorder, other than ME/CFS, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively
3. Current use of psychomotor stimulants, antipsychotics, or benzodiazepines.
4. Use of opioid medications for more than two weeks within the last two years or any use in the last month.
5. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week).
6. Any more than occasional use of cannabis, defined as a score \>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire.
7. Any use of other illicit drugs or misuse of prescription medications, defined as a score \>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire.
8. Condition or injury affecting grip.
9. Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated.
10. Contraindications to MRI, including ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body, implanted cardiac pacemaker, auto-defibrillator, or pump, non-removable body piercing, claustrophobia, inability to lie supine for 90 minutes, pregnancy, or plans to become pregnant during the study.
11. Members of the NINDS BNU and their family members.

Contacts and Locations

Study Contact

Nicholas J Madian, Ph.D.

CONTACT

(301) 480-9787

nicholas.madian@nih.gov

Eric M Wassermann, M.D.

CONTACT

(301) 496-0151

wassermanne@nih.gov

Principal Investigator

Eric M Wassermann, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Eric M Wassermann, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01

Study Completion Date2034-06-30

Study Record Updates

Study Start Date2025-01-01

Study Completion Date2034-06-30

Terms related to this study

Keywords Provided by Researchers

Punishment
Fatigue Syndrome, Chronic
Pain
Physical Exertion
Effort
Brain
Magnetic Resonance Imaging
Neuroimaging
Psychophysics
Reward

Additional Relevant MeSH Terms

Fatigue Syndrome, Chronic