Fatigue Syndrome, ChronicEarly Phase 1NCT06472622
Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort
A Early Phase 1 study testing Thermal Pain Stimulation and Physical Effort Stimulation in people with Fatigue Syndrome, Chronic, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Fatigue Syndrome, Chronic
- What is being tested?
- Thermal Pain Stimulation and Physical Effort Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to 30 Jun 2034
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy Controls: In order to be eligible to participate in this study as a healthy control, an individual must meet all the following criteria:
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18-50 (inclusive).
- Good general health as evidenced by medical history and/or physical examination.
- ME/CFS Patients: In order to be eligible to participate in this study as an ME/CFS patient, an individual must meet all the following criteria:
Show all 10Show fewer
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18-50 (inclusive).
- 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.
Who cannot join
- Healthy Controls:
- 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.
- 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.
- Current use of medications acting primarily on the central nervous system, such as antidepressants, stimulants, etc.
- Use of opioid medications for more than two weeks within the last two years or any use in the last month.
- 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).
Show all 27Show fewer
- 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.
- 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.
- Condition or injury affecting grip.
- Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated.
- 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, known pregnancy, or plans to become pregnant during the study.
- Members of the NINDS BNU and their family members.
- Non-English speakers will be excluded from the study as several study instruments do not have validated translations.
- ME/CFS Patients:
- 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.
- 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
- affect the individual s ability to cooperate with study procedures.
- Current use of psychomotor stimulants, antipsychotics, or benzodiazepines.
- Use of opioid medications for more than two weeks within the last two years or any use in the last month.
- 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).
- 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.
- 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.
- Condition or injury affecting grip.
- Condition or injury affecting extremities that would alter peripheral sensitivity to painful thermal stimuli or would otherwise cause such stimuli to be contraindicated.
- 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, known pregnancy, or plans to become pregnant during the study.
- Members of the NINDS BNU and their family members.
- Non-English speakers will be excluded from the study as several study instruments do not have validated translations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Eric Wassermann, M.D., 301-496-0151, wassermanne@nih.gov
Nicholas Madian, Ph.D., (301) 496-0220, nicholas.madian@nih.gov
About this study
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.
Read more
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.
Read the detailed description
Study Description:
This protocol will examine the associations between brain activation and the subjective unpleasantness associated with pain and physical effort in healthy individuals. We have developed two behavioral tasks for administration during neuroimaging: a Thermal Pain Rating task and a Physical Effort Rating task, which will allow us to identify brain regions in which activity is associated with the unpleasantness of these experiences. We hypothesize that the unpleasantness of the experiences will be associated with activity in a recently identified network of brain regions thought to be involved in computing subjective value, known as the subjective valuation network (SVN).
Objectives:
Primary Objectives:
- Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain.
- Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort.
Endpoints:
Primary Endpoints:
- SVN regions in which activity is significantly associated with unpleasantness of pain.
- SVN regions in which activity is significantly associated with unpleasantness of physical effort.
- Conditions
- Fatigue Syndrome, Chronic
- Being tested
- Thermal Pain Stimulation, Physical Effort Stimulation
- Keywords
- Punishment, Fatigue Syndrome, Chronic, Pain, Physical Exertion, Effort, Brain, Magnetic Resonance Imaging, Neuroimaging, Psychophysics, Reward
- Medical subject headings
- Fatigue Syndrome, Chronic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Pain StimulationDevice
Thermal pain will be administered during fMRI neuroimaging via a thermal stimulation device (Medoc Ltd., Advanced Medical System, Israel; 510K: K052357; K041908; K922052) to examine brain activity corresponding to the experience of this stimulus. This device and associated system carries an FDA 510 (K) clearance.
Physical Effort StimulationDevice
Physical effort will be administered during fMRI neuroimaging via a hand dynamometer attachment for a physiological monitoring system (BIOPAC Systems, Inc., Goleta, CA, USA) to examine brain activity corresponding to the experience of this stimulus. This device has not received pre-marked approval or 510 (K) clearance by the FDA.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | This is a single-arm study. The order of intervention administration will be counterbalanced within this single arm. Receives: Device: Thermal Pain Stimulation; Device: Physical Effort Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain.
SVN regions in which activity is significantly associated with unpleasantness of pain.
Measured: The measurement will be assessed concurrently with thermal pain stimulus administration during the fMRI procedure associated with one of the study visits, 1-31 days following the visit for the first session.
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort.
The SVN has been hypothesized to play a role in producing the unpleasantness of negative experiences including effort.
Measured: The measurement will be assessed concurrently with physical effort stimulus administration during the fMRI associated with one of the study visits, 1-31 days following the visit for the first session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start9 Apr 2025
- Primary completion30 Jun 2034 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472622
- Sponsor's protocol ID
- 10001925
- Other IDs
- 001925-N
- Status last verified
- 16 Sep 2026
- First submitted
- 22 Jun 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not been determined if data analysis based on IPD is beneficial or feasible. This will be evaluated at a later time.
Publications
Zald DH, Treadway MT. Reward Processing, Neuroeconomics, and Psychopathology. Annu Rev Clin Psychol. 2017 May 8;13:471-495. doi: 10.1146/annurev-clinpsy-032816-044957. Epub 2017 Mar 15.
PubMed 28301764Chong TT, Bonnelle V, Manohar S, Veromann KR, Muhammed K, Tofaris GK, Hu M, Husain M. Dopamine enhances willingness to exert effort for reward in Parkinson's disease. Cortex. 2015 Aug;69:40-6. doi: 10.1016/j.cortex.2015.04.003. Epub 2015 Apr 20.
PubMed 25967086Peters J, Buchel C. Overlapping and distinct neural systems code for subjective value during intertemporal and risky decision making. J Neurosci. 2009 Dec 16;29(50):15727-34. doi: 10.1523/JNEUROSCI.3489-09.2009.
PubMed 20016088Levy DJ, Glimcher PW. The root of all value: a neural common currency for choice. Curr Opin Neurobiol. 2012 Dec;22(6):1027-38. doi: 10.1016/j.conb.2012.06.001. Epub 2012 Jul 3.
PubMed 22766486Basten U, Biele G, Heekeren HR, Fiebach CJ. How the brain integrates costs and benefits during decision making. Proc Natl Acad Sci U S A. 2010 Dec 14;107(50):21767-72. doi: 10.1073/pnas.0908104107. Epub 2010 Nov 30.
PubMed 21118983
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort
- ClinicalTrials.gov ID
- NCT06472622
- Acronym / sponsor ID
- 10001925
- Conditions
- Fatigue Syndrome, Chronic
- Keywords
- Punishment, Fatigue Syndrome, Chronic, Pain, Physical Exertion, Effort, Brain, Magnetic Resonance Imaging, Neuroimaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 30 Jun 2034 (estimated)
- Study completion
- 30 Jun 2034 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
This protocol will examine the associations between brain activation and the subjective unpleasantness associated with pain and physical effort in healthy individuals. We have developed two behavioral tasks for administration during neuroimaging: a Thermal Pain Rating task and a Physical Effort Rating task, which will allow us to identify brain regions in which activity is associated with the unpleasantness of these experiences. We hypothesize that the unpleasantness of the experiences will be associated with activity in a recently identified network of brain regions thought to be involved in computing subjective value, known as the subjective valuation network (SVN).
Objectives:
Primary Objectives:
- Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain.
- Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort.
Endpoints:
Primary Endpoints:
- SVN regions in which activity is significantly associated with unpleasantness of pain.
- SVN regions in which activity is significantly associated with unpleasantness of physical effort.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Thermal Pain Stimulation, Device: Physical Effort StimulationThis is a single-arm study. The order of intervention administration will be counterbalanced within this single arm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy Controls: In order to be eligible to participate in this study as a healthy control, an individual must meet all the following criteria:
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18-50 (inclusive).
- Good general health as evidenced by medical history and/or physical examination.
Key exclusion criteria (27 listed)
- 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.
- 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.
- Current use of medications acting primarily on the central nervous system, such as antidepressants, stimulants, etc.
- Use of opioid medications for more than two weeks within the last two years or any use in the last month.
- 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).
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 |
|---|---|---|
| Thermal Pain StimulationThermal pain will be administered during fMRI neuroimaging via a thermal stimulation device (Medoc Ltd., Advanced Medical System, Israel; 510K: K052357; K041908; K922052) to examine brain activity corresponding to the experience of this stimulus. This device and associated system carries an FDA 510 (K) clearance. | Device | Single Arm |
| Physical Effort StimulationPhysical effort will be administered during fMRI neuroimaging via a hand dynamometer attachment for a physiological monitoring system (BIOPAC Systems, Inc., Goleta, CA, USA) to examine brain activity corresponding to the experience of this stimulus. This device has not received pre-marked approval or 510 (K) clearance by the FDA. | Device | Single Arm |
Primary outcome
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain.
Time frame: The measurement will be assessed concurrently with thermal pain stimulus administration during the fMRI procedure associated with one of the study visits, 1-31 days following the visit for the first session.
SVN regions in which activity is significantly associated with unpleasantness of pain.
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort.
Time frame: The measurement will be assessed concurrently with physical effort stimulus administration during the fMRI associated with one of the study visits, 1-31 days following the visit for the first session.
The SVN has been hypothesized to play a role in producing the unpleasantness of negative experiences including effort.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 28301764Zald DH, Treadway MT. Reward Processing, Neuroeconomics, and Psychopathology. Annu Rev Clin Psychol. 2017 May 8;13:471-495. doi: 10.1146/annurev-clinpsy-032816-044957. Epub 2017 Mar 15.
- Background: PubMed 25967086Chong TT, Bonnelle V, Manohar S, Veromann KR, Muhammed K, Tofaris GK, Hu M, Husain M. Dopamine enhances willingness to exert effort for reward in Parkinson's disease. Cortex. 2015 Aug;69:40-6. doi: 10.1016/j.cortex.2015.04.003. Epub 2015 Apr 20.
- Background: PubMed 20016088Peters J, Buchel C. Overlapping and distinct neural systems code for subjective value during intertemporal and risky decision making. J Neurosci. 2009 Dec 16;29(50):15727-34. doi: 10.1523/JNEUROSCI.3489-09.2009.
- Background: PubMed 22766486Levy DJ, Glimcher PW. The root of all value: a neural common currency for choice. Curr Opin Neurobiol. 2012 Dec;22(6):1027-38. doi: 10.1016/j.conb.2012.06.001. Epub 2012 Jul 3.
- Background: PubMed 21118983Basten U, Biele G, Heekeren HR, Fiebach CJ. How the brain integrates costs and benefits during decision making. Proc Natl Acad Sci U S A. 2010 Dec 14;107(50):21767-72. doi: 10.1073/pnas.0908104107. Epub 2010 Nov 30.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It has not been determined if data analysis based on IPD is beneficial or feasible. This will be evaluated at a later time.
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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.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Thermal Pain Stimulation and Physical Effort Stimulation in people with Fatigue Syndrome, Chronic, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 10 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas J Madian, Ph.D. ((301) 480-9787, nicholas.madian@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain. (time frame: The measurement will be assessed concurrently with thermal pain stimulus administration during the fMRI procedure associated with one of the study visits, 1-31 days following the visit for the first session.). The study lists 2 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 NCT06472622, 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 18 Sep 2026.