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History of Changes for Study: NCT02669212
Chronic Fatigue Syndrome
Latest version (submitted March 21, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 29, 2016 None (earliest Version on record)
2 October 6, 2016 Contacts/Locations, Study Status, Outcome Measures, Study Description, Study Identification, References, Eligibility and Study Design
3 October 7, 2016 Study Status
4 October 13, 2016 Study Status
5 December 1, 2016 Recruitment Status, Study Status, References and Contacts/Locations
6 December 6, 2016 Recruitment Status, Study Status, References and Contacts/Locations
7 December 14, 2016 Study Status
8 January 12, 2017 Study Design, Study Description and Study Status
9 January 19, 2017 Study Status
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11 January 24, 2017 Study Description and Study Status
12 March 30, 2017 Study Status and Eligibility
13 April 4, 2017 Study Status
14 April 21, 2017 Study Design and Study Status
15 June 30, 2017 Study Status
16 July 19, 2017 Eligibility and Study Status
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20 September 30, 2017 Eligibility and Study Status
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23 December 13, 2017 Study Status
24 December 22, 2017 Study Status
25 March 27, 2018 Contacts/Locations and Study Status
26 June 6, 2018 Eligibility and Study Status
27 June 9, 2018 Study Status
28 July 3, 2018 Study Description and Study Status
29 July 11, 2018 Study Description and Study Status
30 August 8, 2018 Oversight and Study Status
31 August 11, 2018 Oversight and Study Status
32 September 15, 2018 Study Description and Study Status
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34 September 27, 2018 Study Status and Study Description
35 October 5, 2018 Study Description and Study Status
36 January 1, 2019 Study Status and Study Design
37 January 5, 2019 Study Status
38 April 9, 2019 Study Description and Study Status
39 April 12, 2019 Eligibility, Study Status, Arms and Interventions and Study Description
40 April 17, 2019 Study Status
41 May 2, 2019 Study Status, Eligibility and Study Description
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59 August 24, 2019 Study Status, Arms and Interventions and Outcome Measures
60 August 27, 2019 Study Description and Study Status
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73 January 1, 2020 Study Description and Study Status
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75 January 15, 2020 Study Status
76 March 12, 2020 Study Design, Arms and Interventions, Eligibility, Study Status, Outcome Measures and Study Description
77 March 28, 2020 Study Description and Study Status
78 April 1, 2020 Study Description and Study Status
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80 June 27, 2020 Study Description and Study Status
81 August 15, 2020 Study Status
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83 October 3, 2020 Contacts/Locations, Study Description and Study Status
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94 January 7, 2021 Eligibility, Study Description and Study Status
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102 March 12, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and References
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119 July 16, 2021 Recruitment Status, Contacts/Locations, Study Status, Study Design and References
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131 January 4, 2022 Study Description and Study Status
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133 January 12, 2022 Recruitment Status, Study Status, Contacts/Locations, Study Design and References
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Results Submission Events
211 March 21, 2023 Arms and Interventions, Study Status, Outcome Measures, Document Section, Results, Eligibility, Study Design and Study Description
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Study NCT02669212
Submitted Date:  January 29, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 160058
Brief Title: Chronic Fatigue Syndrome
Official Title: Chronic Fatigue Syndrome
Secondary IDs: 16-N-0058
Open or close this module Study Status
Record Verification: January 2016
Overall Status: Recruiting
Study Start: January 2016
Primary Completion: September 2018 [Anticipated]
Study Completion:
First Submitted: January 29, 2016
First Submitted that
Met QC Criteria:
January 29, 2016
First Posted: February 1, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 29, 2016
Last Update Posted: February 1, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

Background:

Post-infectious chronic fatigue syndrome (PI-CFS) refers to long-lasting fatigue and inability to exercise that can occur after a person has an infection. It can also cause pain, sleep problems, depression, and anxiety. Researchers want to learn more about its causes.

Objective:

To learn more about PI-CFS.

Eligibility:

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

have CFS that started after an infection

OR had Lyme disease, were treated, and don t have fatigue symptoms

OR have a functional movement disorder

OR are healthy volunteers

Design:

Participants will be initially screened in the outpatient clinic with:

Medical history

Physical exam

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

Blood and urine collected

Questions about the participant s life and how they are feeling

Questions from a psychologist

Qualified participants will have:

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

An activity monitor to wear and diary to keep track of daily activities and amount of fatigue

Saliva test

Tests of body functions such as sweating and breathing, being upright, blood pressure, and heart rate.

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.

Medications will be reviewed during screening. Participants may be asked to taper off certain medicines.

After screening participants will return home. They will taper off medications and report any problems. They will also use the activity monitor and fatigue diary.

Participants will return for a 1-week inpatient hospital visit. During the visit, participants will perform a stationary bike exercise test twice. The purpose of the exercise test is to make participants tired. Tests will be performed before and after exercise testing. These include:

Questions about how participants are feeling

Samples of saliva, stool, and cheek skin

Thinking and memory tests

Heart monitoring

Measurements of your breath overnight

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.

They may also have, X-rays, and consultations.

Detailed Description:

Objective:

The primary objective is to explore the clinical and biological phenotypes of post-infectious chronic fatigue syndrome (PI-CFS). The secondary objective is to explore the pathophysiology of fatigue across different study groups.

Study population:

Up to 160 persons aged 18-60 will be enrolled as part of 4 study groups: 40 CFS patients whose fatigue began after an infection, 40 non-fatigued participants with a documented history of Lyme disease exposure and treatment, 40 participants with functional movement disorders, and 40 healthy volunteers. The study has a target of completing all study procedures on 20 enrolled participants in each group.

Design:

This is a single-center, exploratory, cross-sectional study of PI-CFS. Participants will have a screening visit over 1-2 days at the NIH Clinical Center followed by a more depth core series of procedures that will be completed during an inpatient admission of 4-6 days. All procedures will be completed on all four of the study groups to allow for optimal inter-group comparisons. Most of the inpatient admission procedures will be completed both before and after a peak exercise test to allow for comparisons before and after an event capable of inducing fatigue.

Outcome measures:

  • Effect of exercise on neurocognition
  • Effect of exercise on brain connectivity
  • Effect of exercise on markers of immune dysfunction and inflammation
  • Effect of exercise on metabolic function
  • Effect of exercise on autonomic function
  • Effect of exercise on gene expression profiles in blood and CSF
  • Characterization of the pattern of microbiome in gut, blood and CSF
  • Characterization of sleep dysfunction
Open or close this module Conditions
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic Fatigue Syndrome
Lyme Disease
Healthy Volunteers
Movement Disorder
Open or close this module Study Design
Study Type: Observational
Time Perspective: Cross-Sectional
Biospecimen Retention:
Biospecimen Description:
Enrollment: 160 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Effect of exercise on neurocognition, brain connectivity, markers of immune dysfunction and inflammation, metabolic function, autonomic function, and gene expression profiles in blood and CSF
[ Time Frame: End of partcipation ]

2. Characterization of the pattern of microbiome in gut, blood and CSF, and 2) sleep dysfunction
[ Time Frame: End of participation ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:
  • INCLUSION CRITERIA:

Inclusion criteria for all participants:

  • Adult participants aged 18-60 years at the time of enrollment.
  • Self-reported completion of at least the 7th grade of school.
  • Ability to speak, read, and understand English.
  • Willing and able to complete all study procedures
  • Participant has a primary care physician at the time of enrollment.
  • Able to provide informed consent.

Additional inclusion criteria for participants with PI-CFS:

  • A self-reported illness narrative of the development of persistent fatigue as the consequence of an acute infection. The persistent fatigue may have an acute onset or become progressively worse over 6 months.
  • Documentation of fatigue starting after an infection by a physician in their medical records.
  • Meet the 2005 Reeves standardized case definition of chronic fatigue syndrome. This includes:
    • Having greater than or equal to 4 symptoms set forth in the 1994 Fukuda criteria.
    • 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 greater than or equal to 70 physical function subscale, or greater than or equal to 50 on role physical subscale, or greater than or equal to 75 on social function subscale, or greater than or equal to 66 on emotional subscale.
    • Symptom validity as determined using the Centers for Disease Control Symptom Inventory: score of greater than or equal to 25 on the Symptom Inventory Case Definition subscale.
  • Fatigue onset greater than 6 months but less than 5 years prior to enrollment.

Additional inclusion criteria for healthy volunteer group:

None

Additional inclusion criteria for Documented Lyme Infection Asymptomatic group:

  • 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/):
    • 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.
    • 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.
  • 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.

Additional inclusion criteria for functional movement disorders group:

  • A self-reported illness narrative of the development of persistent, paroxysmal, or episodic motor symptoms as the consequence of an acute event or exposure or occurring with an acute onset.
  • Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria.
    • Documented psychogenic movement disorder: persistent relief by psychotherapy, suggestion or placebo, or observed without the movement disorder when unobserved.
    • Clinically established psychogenic movement disorder: inconsistent over time or incongruent with a classical movement disorder, plus other false neurological signs, multiple somatizations, obvious psychiatric disturbances, distractibility, or deliberate slowness.
  • The diagnosis of FMD must be made by a neurologist and documented in their medical records.

EXCLUSION CRITERIA:

Exclusion criteria for all participants:

  • Active infection (e.g. influenza, urinary tract infection) by history, physical examination, or laboratory evaluations at the time of enrollment
  • Current or past psychotic disorder including depression with psychosis, bipolar disorder, and schizophrenia
  • 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
  • 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
  • Current suicidal ideation
  • History of head injury with loss of consciousness, or history of head injury with amnesia lasting greater than a few seconds
  • 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 inpatient admission. 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.
  • Women who are pregnant, actively seeking to become pregnant, or have been pregnant in the year prior to study enrollment.
  • Current or previous malignancy. Certain dermatologic malignancies (e.g. basal cell carcinoma) will be allowed.
  • Current immunologic disorder (e.g. Type 1 diabetes, rheumatoid arthritis)
  • 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
  • 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).
  • 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.
  • Inability to perform the bicycling exercise task.
  • Not willing to allow for research samples to be shared with other researchers.
  • Employees or staff at NIH that are directly supervised by the primary investigator or associate investigators.

Additional exclusion criteria for participants with CFS:

  • Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).
  • PI-CFS disease severity that makes it impossible for the volunteer to leave the home or requires inpatient treatment.
  • Suspected, probable, or confirmed Lyme disease per 2011 CDC Lyme Disease National Surveillance Case Definitions.
  • Underlying illness that may cause fatigue such as thyroid dysfunction, hepatitis, or other systemic diseases.

Additional exclusion criteria for healthy volunteer group:

  • Clinical relevant fatigue as determined using the Multidimensional Fatigue Inventory (MFI): score of > 8 on the general fatigue subscale or > 6 on the reduced activity subscale.
  • Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

Additional exclusion criteria for Documented Lyme Infection Asymptomatic group:

  • Clinical relevant fatigue as determined using the Multidimensional Fatigue Inventory (MFI): score of > 8 on the general fatigue subscale or > 6 on the reduced activity subscale.
  • Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

Symptoms or diagnosis of Post-Lyme Disease Syndrome

Additional exclusion criteria for functional movement disorders group:

  • Clinical relevant fatigue as determined using the Multidimensional Fatigue Inventory (MFI): score of > 8 on the general fatigue subscale
  • Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).
Open or close this module Contacts/Locations
Central Contact Person: Brian T Walitt, M.D.
Telephone: (301) 451-1683
Email: brian.walitt@nih.gov
Study Officials: Avindra Nath, M.D.
Principal Investigator
National Institute of Neurological Disorders and Stroke (NINDS)
Locations: United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
[Recruiting]
Bethesda, Maryland, United States, 20892
Contact:Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 Ext. TTY8664111010 prpl@mail.cc.nih.gov
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: NIH Clinical Center Detailed Web Page
Available IPD/Information:

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