Uncovering Neural and Immune Mechanisms of Chronic Pain in Post Treatment Lyme Syndrome
TerminatedNot applicableNCT02687165
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study will investigate (a) neural and immune mechanisms underlying chronic pain in PTLS by comparing a group of PTLS patients and healthy participants on brain imaging, sensory, and immune markers; and (b) assess change in pain, brain imaging (fMRI and MRS), sensory, and immune markers in response to a combination of SNRI and glutamatergic treatment for chronic pain in PTLS (Milnacipran and D-cycloserine).
Study details
- Official title
- Uncovering Neural and Immune Mechanisms of Chronic Pain in Post Treatment Lyme Syndrome
- Conditions
- Post Treatment Lyme Syndrome (PTLS)
- Chronic Pain
- Interventions
- Drug: Milnacipran and D-cycloserine
- Sponsor
- New York State Psychiatric Institute
- Start date
- 2016-01-16
- Primary completion
- 2017-01-16
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. History of Lyme Disease and treatment: 2. Current chronic pain in the musculoskeletal system 3. clinically troubling sensory hypersensitivity (e.g., light or touch) 4. Able to speak and read English 5. Willing to not take other than study centrally acting pharmacologic agents prior to MRI and for the duration of treatment with study medications Exclusion Criteria: 1. Diagnosis of another (not LYME) general medical condition that has a major role in the onset, severity, exacerbation or maintenance of pain, or sensory hypersensitivity. 2. DSM-IV Axis I lifetime diagnosis of Pervasive Developmental Disorder, Autism, Psychotic disorder, Bipolar Disorder, Substance dependence. 3. I current diagnosis of Major Depressive Disorder or substance abuse 4. History of head injury with loss of consciousness (\>5min), neurologic disease, seizures (excluding febrile seizures) or serious unstable medical condition (e.g. cancer, diabetes) 5. Current or recent (last month) opiate use 6. For 2 weeks prior to MRI and diagnostic visit, unable to be free of centrally active medications or treatment methods. These include medications commonly used to treat pain (eg, antidepressants, muscle relaxants, centrallyacting analgesics), as well as transcutaneous electrical nerve stimulation, biofeedback, tender and trigger point injections, acupuncture, and anesthetic or narcotic patches. PRN doses of short acting medications, e.g. acetaminophen, aspirin, and nonsteroidal antiinflammatory agents will be allowed for pain with usage carefully monitored, but patients must be willing to be off of these medications for 24 hours prior to the major evaluations at intake and MRI study visit. Stable doses of non-benzodiazepines will be allowed for sleep (but not tricyclics) 7. Ferromagnetic implants (e.g. pacemaker, etc.) 8. Metal Braces or Retainers 9. Transdermal medicinal patches that cannot be removed 10. Birth at \< 37 weeks gestational age (prior studies have shown dramatic effects on brain structure and function in prematurely born children) 11. Claustrophobia 12. Women will be excluded if they are pregnant, lactating, or not either surgically-sterile or using appropriate methods of birth control. Women must agree to continue using applicable birth control throughout the trial. All women of child-bearing potential must have a negative pregnancy test at the intake visit. 13. Inability to reliably rate intensity of pain in response to a fixed thermal stimulus 14. Inabi…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02687165