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Protocol Details

Myalgic Encephalomyelitis/chronic fatigue syndrome

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-N-0058

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 60

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Children

Special Instructions

Currently Not Provided

Keywords

chronic fatigue syndrome;
Lyme Disease;
Healthy Volunteers;
Movement Disorder

Recruitment Keyword(s)

None

Condition(s)

chronic fatigue syndrome

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

Post-Infectious Myalgic Encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS) refers to long-lasting and disabling fatigue or malaise, inability to recover after exercise, and physical and emotional discomfort that may occur after a person has an infection. Researchers want to learn more about its causes.

Objective:

To learn more about PI-ME/CFS.

Eligibility:

Adults ages 18-60 years who have finished at least 7th grade education and either:

have ME/CFS that started after an infection

OR had Lyme disease, were treated, and returned to normal health

OR are healthy volunteers

Design:

Participants will initially have a 2-5 day inpatient visit at the National Institutes of Health Clinical Center in Bethesda. During the visit, participants will have:

Medical history

Physical exam

Intravenous (IV) line. A thin plastic tube is inserted into a vein.

Blood and urine collected

Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through their IV.

Grip strength tested

Saliva, cheek swab, and stool collected

Tilt table test with measures of body functions such as sweating and breathing, blood pressure, and heart rate and blood and urine sample collection

Collection of blood cells. Participants can choose to have the blood drawn through the IV or through a machine that filters blood cells and returns the liquid blood back into the participant s vein.

Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.

Heart monitoring

Sleep study for participants with PI ME/CFS

Questions about the participant s life and how they are feeling

Questions from a neuropsychologist

Questions from an occupational therapist for participants with PI ME/CFS

Questinos from a nutritionist

After the initial visit participants will return home. Participants evaluated for PI-ME/CFS during the first visit will have their information reviewed by an adjudication panel of experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate in the second study visit.

Eligible participants will be invited back for a second study visit. If a participant was taking certain medications during the first visit, they may be asked to taper off of them prior to the second visit and report any problems. They will also receive an activity monitor, fatigue diary, and nutrition log to use for at least one week prior to their second visit.

Participants who are eligible will return for a 5-10 day inpatient hospital visit at the National Institutes of Health Clinical Center. During the visit, participants will undergo measurements before and up to 96 hours after performing a stationary bike exercise test. The purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests will be performed before and after exercise testing. These include:

Sleeping in a room that measures how the body uses energy with EEG monitoring

Eating a controlled diet

Performing vigorous exercise for 10-15 minutes

Questions about how participants are feeling

Questions about what participants usually eat

Samples of saliva, blood, urine and stool

Wearing an activity monitor

Having an Xray that measures body composition

Thinking and memory tests

Heart monitoring

Transcranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic pulse that affects brain activity.

Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI.

Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.

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Eligibility

INCLUSION CRITERIA:

-Inclusion criteria for all participants

1.Adult participants aged 18-60 years at the time of enrollment.

2.Self-reported completion of at least the 7th grade of school.

3.Ability to speak, read, and understand English.

4.Willing and able to complete all study procedures

5.Participant has a primary care physician at the time of enrollment.

6.Able to provide informed consent.

-Additional inclusion criteria for participants with PI-ME/CFS for the phenotyping visit

1. A self-reported illness narrative of the development of persistent fatigue and post-exertional malaise as the consequence of an acute infection. The persistent fatigue may have an acute onset or become progressively worse over 6 months.

2. Licensed Independent Practitioner documentation of ME/CFS onset:

--Medical documentation of absence of symptoms within one year of ME/CFS onset.

--Documentation of a medical evaluation for symptoms of an acute infection or documentation of a medical evaluation of persistent symptoms within 2 months following an assumed infection.

3. Persistent fatigue and PEM onset less than 5 years prior to enrollment.

-Additional inclusion criteria for participants with PI-ME/CFS for the exercise stress visit

1. Be unanimously considered to be a case of PI-ME/CFS by the protocol s adjudication committee.

2. Meet the 1994 Fukuda Criteria and the 2003 Canadian Consensus Criteria for Myalgic Encephalomyelitis/chronic fatigue syndrome.

3. Have moderate to severe clinical symptom severity:

--Severe fatigue as determined using the Multidimensional fatigue Inventory (MFI): score of greater than or equal to 13 on the general fatigue subscale or greater than or equal to 10 on the reduced activity subscale.

--Functional impairment as determined using the Short-Form 36 (SF-36): score of less than or equal to 70 physical function subscale, or less than or equal to 50 on role physical subscale, or less than or equal to 75 on social function subscale

-Additional inclusion criteria for healthy volunteer group

None

-Additional inclusion criteria for Documented Lyme Infection - Asymptomatic group

1. Medical record documentation of fulfilling the probable or confirmed 2011 CDC Lyme Disease National Surveillance Case Definitions (http://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2011/):

a. Probable: A case of physician-diagnosed Lyme disease that meets laboratory criteria of evidence of infection (positive culture for B.burgdoferi, or two-tiered testing using criteria, or single-tier IgG immunoblot seropositivity using criteria, or CSF antibody positive for B.burgdoferi by Enzyme Immunoassay or Immunofluorescence Assay, when the titer is higher than it was in serum.

b. Confirmed: A case of erythema migrans with a known exposure, or a case of erythema migrans with laboratory evidence of infection and without a known exposure, or a case with at least one late manifestation that has laboratory evidence of infection.

2.Have received accepted antibiotic treatment for Lyme Disease greater than or equal to 6 months prior to enrollment but less than 5 years prior to enrollment documented in their medical records.

EXCLUSION CRITERIA:

-Exclusion criteria for all participants

1. Current or past psychotic disorder including depression with psychosis, bipolar disorder, and schizophrenia

2. Current DSM-5-defined major depression disorder, generalized anxiety disorder, post-traumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen

3. Current or prior substance use disorder as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5) or positive urine toxicology results at enrollment

4. Current suicidal ideation

5. History of head injury with loss of consciousness or amnesia lasting greater than a few seconds within lasta five years or lasting greater than 5 minutes at any point during their lifetime.

6. Women who are pregnant, actively seeking to become pregnant, or have been pregnant in the year prior to study enrollment.

7. Current or previous malignancy. Certain dermatologic malignancies (e.g. basal cell carcinoma) will be allowed. A history of malignancy that have fully resolved with surgical resection only (i.e. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.

8. Current immunologic disorder (e.g. Type 1 diabetes, rheumatoid arthritis)

9. Current or previous long term immune suppressive or immunomodulatory therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment

10. Any medical condition (eg, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis, poorly controlled asthma) that would make the study procedures risky for the participant (e.g. exercise-induced angina and asthma) or that may confound the study results (e.g. untreated obstructive sleep apnea, severe osteoarthritis).

11. Participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.

12. Inability to perform the bicycling exercise task.

13. Clinically significant claustrophobia

14. Not willing to allow for research samples to be shared with other researchers.

15. Employees or staff at NIH that are directly supervised by the primary investigator or associate investigators.

-Additional exclusion criteria for participants with PI-ME/CFS for phenotyping visit

1. Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

2. PI-ME/CFS disease severity that makes it impossible for the volunteer to leave the home or requires inpatient treatment.

3. Suspected, probable, or confirmed Lyme disease per 2011 CDC Lyme Disease National Surveillance Case Definitions.

4. Underlying illness that may cause fatigue such as thyroid dysfunction, hepatitis, or other systemic diseases.

-Additional exclusion criteria for participants with PI-ME/CFS for exercise stress visit

1. Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability that the potential participant is either unwilling or clinically unable to safely wean off for the duration of the period of the exercise stress visit. The possibility for a potential participant to be weaned off medication will be cooperatively determined by both the clinical investigative team and personal physicians. Examples of medications that influence brain excitability include tricyclic antidepressants, hypnotic, antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants, dopaminergic medications, and sleep medications.

-Additional exclusion criteria for healthy volunteer group

1. Substantial daily fatigue as determined using PROMIS-SF fatigue: score of > 17.

2. Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

3. Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability

-Additional exclusion criteria for Documented Lyme Infection - Asymptomatic group

1. Substantial daily fatigue as determined using the Multidimensional fatigue Inventory (MFI): score of > 8 on the general fatigue subscale or >6 on the reduced activity subscale.

2. Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

3. Symptoms or diagnosis of Post-Lyme Disease syndrome

4. Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Avindra Nath, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Angelique Gavin
National Institute of Neurological Disorders and Stroke (NINDS)

(301) 496-1788
mecfsemail@nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT02669212

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