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Noninvasive Neuromodulation Of The Subjective Value Network In Chronic Pain

NCT07798908 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-09-03

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Neurogenic Pain

Interventions

DEVICE

Transcranial magnetic stimulation

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.

OTHER

Sham

Off-target control stimulation intervention

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Eric M Wassermann, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2030-12-01
Completion
2030-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07798908 on ClinicalTrials.gov