Central Sensitization clinical trials

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

This study that has the following goals: a) To systematically characterize symptomatology of patients with PTLS by conducting multimodal sensory and neurocognitive assessments and comparing patients with PTLS to healthy controls and to identify biomarkers associated with chronic pain and sensory hypersensitivity among patients with PTLS, c) To investigate whether pharmacologic treatment with milnacipran is associated with clinical improvement chronic pain and physical functioning and with specific changes both in the cerebral and ventricular neurochemistry and in the neural activation patterns d) To investigate whether augmentation with a glutamatergic agent (D-cycloserine) can increase the pain -alleviating effect of an SNRI agent (milnacipran) among patients with PTLS First, patients with chronic PTLS pain and healthy controls will carefully assessed and compared on the brain imaging measures, sensory battery, neuropsychologic tests, and immune markers. After this extensive clinical and neural markers assessment, patients with PTLS and chronic pain will be randomized to (i) 12 weeks of milnacipran +d-cycloserine augmentation, or (ii) 12 weeks of milnacipran + placebo augmentation. Milnacipran (an SNRI) reduces both pain and depression and was shown in previos studies to reduce pain in fibromyalgia. D-Cycloserine (as a glutamate modulator) as a SNRI adjunct was shown to further reduce depression and in animal models to reduce pain. Primary outcome measure will be improvement in pain on visual analog scale, physical functioning and quality of life. All patients will undergo sensory, immune, glycine, self-reports, neuropsychologic testing, and neural markers assessments pre- and post-treatment.