National Institute of Neurological Disorders and Stroke (NINDS)
Study Description: This is an outpatient pilot study of the feasibility and tolerability of transcranial magnetic stimulation, directed to the network of brain regions responsible for assigning value to events, in patients with chronic pain. The primary hypothesis is that this study intervention will be feasible and tolerated well. The secondary hypothesis is that such study intervention will reduce the severity of chronic pain. Objectives: Primary Objective: To establish the feasibility and tolerability of multi-day TMS in chronic pain patients. Secondary Objective: To obtain preliminary information on whether network-targeted TMS changes chronic pain ratings. Exploratory Objectives: To evaluate effects of study intervention on moment-to-moment pain and emotional experience, continuous actigraphy, HEAL Core Common Data Elements, and, when fMRI is feasible, resting state functional connectivity before and after study intervention blocks. Endpoints: Primary Endpoint: Completion of at least two consecutive study intervention blocks, including one real on-target stimulation block and one off-target control stimulation block. Secondary Endpoint: Mean change in self-rated pain on the McGill Pain Questionnaire-Short Form after real on-target study intervention blocks compared with off-target control blocks. Exploratory Endpoints: Mean changes in Ecological Momentary Assessment, actigraphy, HEAL Core Common Data Elements, and, when fMRI is feasible, resting state functional connectivity after real on-target stimulation blocks compared with off-target control blocks.
Study Description: This is an outpatient pilot study of the feasibility and tolerability of transcranial magnetic stimulation, directed to the network of brain regions responsible for assigning value to events, in patients with chronic pain. The primary hypothesis is that this study intervention will be feasible and tolerated well. The secondary hypothesis is that such study intervention will reduce the severity of chronic pain. Objectives: Primary Objective: To establish the feasibility and tolerability of multi-day TMS in chronic pain patients. Secondary Objective: To obtain preliminar…
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Participant must be willing to comply with all study procedures and be available for the duration of the study. * Male and female patients of 18 years of age or older. * Diagnosed with peripheral or central neuropathic pain of at least three months duration and phenotyped by the PRC under protocol 16-AT-0077, and on a stable pain medication regimen * In stable health as determined by study personnel, and without acute medical or mental illness for the past six…
Delivered to parietal region with connectivity to medial orbitofrontal cortex, based on individual functional connectivity. Treatment blocks consist of three days of real or off-target (sham) stimulation.
Off-target control stimulation intervention