Chronic Neurogenic PainPhase 1NCT07798908
Noninvasive Neuromodulation Of The Subjective Value Network In Chronic Pain
A Phase 1 study testing Transcranial magnetic stimulation in people with Chronic Neurogenic Pain, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Neurogenic Pain
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 weeks
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Concurrent epilepsy or history of seizure in the last year
- Inability to provide informed consent
- Ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body
- Implanted electronics contraindicated for MRI or TMS, such as cardiac pacemaker or auto-defibrillator or pumps
- Non-removable body piercings
Show all 14Show fewer
- Claustrophobia severe enough to preclude MRI
- Inability to lie supine for 1 hour
- Members of the NINDS BNU or NIHPRC
- Individuals with elevated risk and potential contraindications to MRI, as defined by the NIH NMR center guidelines.
- Known hearing loss, as assessed by asking the potential participant whether they have hearing loss
- Have difficulties with communication that make subjective pain assessment impossible or unreliable
- Have active medical or psychiatric health issues that create additional and substantial adverse risks related to study procedures
- Pregnant participants or participants planning to become pregnant during the study. At enrollment/baseline, pregnancy status will be assessed by asking participants capable of becoming pregnant whether they are pregnant or planning to become pregnant during the study. Before each fMRI, participants capable of becoming pregnant must have a negative urine pregnancy test to continue with the fMRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Noninvasive Neuromodulation of the Subjective Value Network in Chronic Pain
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.
Read more
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.
Read the detailed description
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
- Being tested
- Transcranial magnetic stimulation, Sham
- Keywords
- Chronic Pain, Reward system, Transcranial Magnetic Stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
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.
ShamOther
Off-target control stimulation intervention
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Other | Real on-target > off-target control > off-target control > real on-target Receives: Device: Transcranial magnetic stimulation; Other: Sham |
| Sequence B | Other | Sequence B = off-target control > real on-target > real on-target > off-target control. Receives: Device: Transcranial magnetic stimulation; Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the tolerability and feasibility of transcranial magnetic stimulation in chronic pain patients.
Successful completion of targeting MRI and a 3-day course of stimulation.
Measured: 36 months
Secondary outcomes (1)
To measure effects on pain, using an N-of-1 design and cross-sectional and continuous measures
The change in self-rated pain and function on an Ecological Momentary Assessment.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neurogenic PainStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798908
- Sponsor's protocol ID
- 10002566
- Other IDs
- 002566-N
- Status last verified
- 24 Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Neuromodulation of the Subjective Value Network in Chronic Pain
- ClinicalTrials.gov ID
- NCT07798908
- Acronym / sponsor ID
- 10002566
- Conditions
- Chronic Neurogenic Pain
- Keywords
- Chronic Pain, Reward system, Transcranial Magnetic Stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Other | Device: Transcranial magnetic stimulation, Other: ShamReal on-target > off-target control > off-target control > real on-target |
| Sequence B | Other | Device: Transcranial magnetic stimulation, Other: ShamSequence B = off-target control > real on-target > real on-target > off-target control. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 weeks
Key exclusion criteria (14 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Concurrent epilepsy or history of seizure in the last year
- Inability to provide informed consent
- Ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body
- Implanted electronics contraindicated for MRI or TMS, such as cardiac pacemaker or auto-defibrillator or pumps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationDelivered 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. | Device | Sequence A, Sequence B |
| ShamOff-target control stimulation intervention | Other | Sequence A, Sequence B |
Primary outcome
To evaluate the tolerability and feasibility of transcranial magnetic stimulation in chronic pain patients.
Time frame: 36 months
Successful completion of targeting MRI and a 3-day course of stimulation.
1 secondary outcome
To measure effects on pain, using an N-of-1 design and cross-sectional and continuous measures
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial magnetic stimulation in people with Chronic Neurogenic Pain, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisa J Johnson ((240) 603-0537, alisa.johnson@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the tolerability and feasibility of transcranial magnetic stimulation in chronic pain patients. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.