Uncovering Neural and Immune Mechanisms of Chronic Pain in Post Treatment Lyme Syndrome

Stopped early · Not applicable · Has a placebo group

Conditions studied: Post Treatment Lyme Syndrome (PTLS), Chronic Pain

In brief

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).

Key facts

Study ID

NCT02687165

Run by

New York State Psychiatric Institute

People needed

4

Starts

2016-01-16

Expected to finish

2017-01-16

Last updated by the study team

2020-06-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• History of Lyme Disease and treatment:
• Current chronic pain in the musculoskeletal system
• clinically troubling sensory hypersensitivity (e.g., light or touch)
• Able to speak and read English
• Willing to not take other than study centrally acting pharmacologic agents prior to MRI and for the duration of treatment with study medications

You may not qualify if…

• 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.
• DSM-IV Axis I lifetime diagnosis of Pervasive Developmental Disorder, Autism, Psychotic disorder, Bipolar Disorder, Substance dependence.
• I current diagnosis of Major Depressive Disorder or substance abuse
• History of head injury with loss of consciousness (>5min), neurologic disease, seizures (excluding febrile seizures) or serious unstable medical condition (e.g. cancer, diabetes)
• Current or recent (last month) opiate use
• 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)
• Ferromagnetic implants (e.g. pacemaker, etc.)
• Metal Braces or Retainers
• Transdermal medicinal patches that cannot be removed
• Birth at < 37 weeks gestational age (prior studies have shown dramatic effects on brain structure and function in prematurely born children)
• Claustrophobia
• 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.
• Inability to reliably rate intensity of pain in response to a fixed thermal stimulus
• Inability to tolerate sound intensity of fMRI
• Individuals currently successfully treated by medications for their pain.
• History of inability to tolerate treatment with SSRI or SNRI medications or d-cycloserine; or medication induced mania
• Renal insufficiency or congestive heart failure
• Hepatic malfunction Liver Test

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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