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Noninvasive Neuromodulation Of The Subjective Value Network In Chronic Pain

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Re-verified, no change to tracked fields
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07798908
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Chronic Neurogenic Pain
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov