Noninvasive Neuromodulation Of The Subjective Value Network In Chronic Pain

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT07798908
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Chronic Neurogenic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial magnetic stimulation — DEVICE
    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.
  • Sham — OTHER
    Off-target control stimulation intervention

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Dec 1, 2026
Status verified
Aug 2026
Primary completion
Dec 1, 2030
Completion
Dec 1, 2030

Study Design

Enrollment
9 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Other: Sequence A
    Real on-target \> off-target control \> off-target control \> real on-target
  • Other: Sequence B
    Sequence B = off-target control \> real on-target \> real on-target \> off-target control.

Primary Outcome Measure

To evaluate the tolerability and feasibility of transcranial magnetic stimulation in chronic pain patients. [ Time Frame: 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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National Institutes of Health Clinical Center· Bethesda, MD