Neck PainPrTMSNCT06214949
Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)
A study testing Personalized Repetitive Transcranial Magnetic Stimulation in people with Neck Pain, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Personalized Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to May 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Military health care beneficiary for enrollment.
- Over the age of 18 years.
- Presence of chronic neck pain for at least 3 months.
Who cannot join
- History of seizure, bipolar disorder, or schizophrenia.
- Unstable heart or pulmonary disease.
- Brain tumor, active brain infection, history of cerebral vascular accident (CVA), or penetrating brain injury.
- Use of medications that potentially lower seizure threshold without concomitant administration of anticonvulsant drugs that may protect against seizure occurrence.
- Antiviral medications and antipsychotic medications
- Recent withdrawal from sedatives
Show all 16Show fewer
- Substance abuse of phencyclidine, amphetamines, ketamine, and gammahydroxybutyrate
- Not a suitable candidate for the study as determined by the PI.
- Pregnancy, breastfeeding, or plans to become pregnant during the course of the study.
- Presence of metallic hardware in close contact to the discharging coil (e.g. cochlear implants, internal pulse generator).
- Presence of implanted brain electrodes (cortical or deep-brain electrodes).
- Potential participants who score above a certain suicide relevant survey score on the Suicide Behaviors Questionnaire-Revised (SBQ-R), or are judged by expert clinicians to be a serious risk of harm to self, will be excluded.
- Participants cannot have undergone a previous TMS treatment within the last 30 days before the start of study treatment.
- Participants must have reliable and consistent access to the internet to complete surveys when not present in the clinic.
- Participants must not have a clinical diagnosis of insomnia.
- Participants can not be actively partaking in a substance abuse program.
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, 1 recruiting
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Oluwaseyi Gbade-Alabi, MD, 240-688-7145, oluwaseyi.gbade-alabi@usuhs.edu
Miana Atkins, MPH, 240-688-7145, CRSR_Research@usuhs.edu
About this study
Official title: Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) as a Treatment for Chronic Neck Pain
This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.
Read the detailed description
The objective of our proposed research is to (a) assess the efficacy of PrTMS therapy in reducing pain for military health system beneficiaries with chronic neck pain receiving standard of care* at Walter Reed National Military Medical Center, and (b) to describe participants' perceptions of PrTMS treatment and its perceived effect on their pain.
The specific aims for this study are as follows:
Specific Aims
Aim 1a: To assess the efficacy of PrTMS therapy in reducing pain for military health system beneficiaries with chronic neck pain receiving standard of care at Walter Reed National Military Medical Center.
Aim 1b: To describe participants' perceptions of PrTMS treatment and its perceived effect on their pain.
Hypothesis 1a: Participants receiving PrTMS therapy in addition to standard of care will report a significant mean reduction in their pain based on quantitative and qualitative assessments, when compared to standard of care plus sham PrTMS.
Hypothesis 1b: Participant response to PrTMS will be independent of patient demographics (age, race, sex), length of chronic pain, characterization of type of pain (e.g., sharp, burning, aching, etc.), or location of pain (e.g., local vs. radiating).
Outcome Measures:
DVPRS summary pain score and four supplemental questions, measuring activity, sleep, mood, and stress.
Aim 2: To examine the short- and intermediate-term changes in self-reported quality of life and biopsychosocial symptoms related to pain in military health system beneficiaries receiving PrTMS in addition to standard of care for chronic neck pain at Walter Reed National Military Medical Center.
Hypothesis 2: Participants receiving PrTMS therapy will report significantly lower mean scores on PROMIS (fatigue, pain interference, and social isolation) and sleep disturbance, and higher mean PROMIS (physical function and satisfaction with social roles) than participants receiving sham PrTMS across the intervention period and at follow up.
Outcome Measures:
The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) measures are validated, global measures of patient-reported outcomes with standardized scales and computer adaptive testing (CAT). CAT allows for reduced participant burden, as the number of questions asked to arrive at a score are fewer. PROMIS measures have also been recommended as an assessment tool for studies conducted exploring TMS as treatment for pain. To measure the biopsychosocial elements of pain, the following PROMIS measures will be utilized:
- PROMIS Bank v1.0 - Fatigue
- PROMIS Bank v1.1 - Pain Interference
- PROMIS Bank v2.0 - Physical Function
- PROMIS Bank v2.0 - Satisfaction with Social Roles
- PROMIS Bank v1.0 - Social Isolation
Aim 3: To assess the impact that confounding factors such as depression, anxiety, sleep disorders, or PTSD may have on the efficacy of PrTMS as an augmentation to standard of care.
Hypothesis 3: Participants that have high premorbid levels of mental health disease or sleep disturbances will exhibit less response to PrTMS than those who do not.
Outcome Measures:
PCL-5, PHQ-9, SCI, GAD-7 and OURA ring. (see section 10.2)
Aim 4: To assess the short- and intermediate-term changes in plasma neuropeptides, inflammatory proteins and nucleic acids that can serve as blood based biomarkers for pain /stress.
Hypothesis 4: Participants receiving PrTMS therapy will demonstrate significantly lower mean plasma concentrations of tested plasma neuropeptides and inflammatory proteins, as well as associated genetic markers, including mRNA, miRNA, and genomic sequences.
Biological Blood and Serum Measures:
Neuropeptides such as ACTH, NPY, IGF-1, BDNF, NSE, GFAP, S100B; inflammatory proteins, such as IL-1beta, IL-2, IL-6, IL-8, IL-10, IL-12, TNF-alpha, IFN-gamma, MCP1/CCL2, CRP; mRNA; miRNA; and whole genome sequencing (WGS)
- Conditions
- Neck Pain
- Being tested
- Personalized Repetitive Transcranial Magnetic Stimulation, Sham Personalized Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Repetitive Transcranial Magnetic StimulationDevice
Treatment will consist of 15 sessions over 3-4 weeks. Specifically, the active or sham treatments will be conducted ~5 times a week during the treatment phase of the study. The treatment protocol parameters (stimulus location, frequency, duration, and intensity) will be derived from the PrTMS software algorithm which incorporates clinical inputs from neurocognitive surveys and quantitative EEG analysis. The mechanical parameters will adhere to the recommended PrTMS parameters for pain treatment: figure of 8 coil that produces biphasic stimulatory pulses to the central zone cortex, frontal zone cortex, Broca's area, and frontal pre-cortex areas at a stimulation depth of 2 cm. Treatment parameters will be unique to each participant but will remain within known ranges. The frequency will be between 8 and 13 Hz, at an amplitude of 20-30% (approximately 30-40% of RMT), and about 3200-7200 pulses per session. Since parameters are specific to each participant, treatment settings will vary.
Sham Personalized Repetitive Transcranial Magnetic StimulationDevice
Treatment will consist of 15 sessions over the course of 3-4 weeks. More specifically, the active or sham treatments will be conducted roughly 5 times a week during the course of the treatment phase of the study. The TMS system will have three coils, one designated active and the other two unlabeled and identical in appearance, weight, and noises emitted, one of which will be active and one of which will be sham.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Repetitive Transcranial Magnetic Stimulation | Experimental | Not described Receives: Device: Personalized Repetitive Transcranial Magnetic Stimulation |
| Sham Personalized Repetitive Transcranial Magnetic Stimulation | Experimental | Not described Receives: Device: Sham Personalized Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defense & Veterans Pain Rating Scale (DVPRS)
The DVPRS was developed to standardize pain measurement across all health care settings and promote pain assessment and reassessment practices. DVPRS is a visual pain scale to assess individual's pain intensity on a scale of 0-10, with an additional 4 questions to assess pain's interference with the participant's activity, sleep, mood, and stress. The scale has excellent internal reliability and test-retest reliability.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements taken everyday during Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Secondary outcomes (13)
Patient Global Impression of Change (PGIC)
The PGIC outcome measure evaluates a patient's self-reported level of pain and their feelings about treatment effectiveness to determine symptom improvement using a 7 point scale from 1-7. Higher scores indicate a greater improvement while lower scores indicate less improvement or even worsening of a condition.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
TMS Tolerability Worksheet (TTW)
The TTW is administered after each PrTMS session to accurately track and record tolerability of TMS therapy as well as frequency and severity of the known minor negative side effects of TMS, such as headaches.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Pain Anxiety Symptom Scale Short Form 20 (PASS)
The PASS measures anxiety and fear specifically related to pain on a scale from 0 (never) to 5 (always).
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Sleep Condition Indicator (SCI)
The SCI is an 8-item self-report measure that evaluates insomnia disorder where answers to a given item are weighted from 0 (affected sleep) to 4 (no affected sleep). A higher score is indicative of better sleep.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7 is a 7-item self-report measure that assesses an individual's level of anxiety on daily life using a scale from 0 (Not at all) to 3 (Nearly every day). Higher scores indicate higher levels of anxiety.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Patient Health Questionnaire (PHQ-9)
The (PHQ-9) is a 9-item measure of depression through affect on everyday life on a scale of 0 (Not at all) to 3 (Nearly every day). Higher scores are indicative of higher levels of depression.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Quantitative Analgesic Questionnaire (QAQ)
The QAQ is a tool used to identify and comprehensively document medication use and adherence to prescriptions based on patient self-reports.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Suicide Behaviors Questionnaire-Revised (SBQ-R)
The SBQ-R is a self-report questionnaire targeted to assess suicidal risk factors in individuals aged 13 and older. Responses will be scored based on how participants respond with values between 1 and 6 points. Higher scores are more indicative of suicidal risk.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-report questionnaire on the presence and severity of PTSD symptoms. Responses range from values of 0 (Not at all) to 4 (Extremely) where higher scores are more indicative of severe PTSD.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Patient Reported Outcomes Measurement Information System (PROMIS) Scales.
The PROMIS scales will be used in this study to examine effects of TMS on quality of life using the following scales: Fatigue, Pain Interference, Physical Function, Satisfaction with Social Roles, and Social Isolation. Responses will vary from Never (scored as 0) to Always (scored as 4). Higher scores being more indicative of the concept being measured.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Pittsburgh Sleep Quality Index (PSQI)
The PSQ-I is an effective instrument used to measure the quality and patterns of sleep in adults. Responses to questions about sleep will be scored from 0 (better sleep quality) to 3 (worse sleep quality). Higher overall scores being indicative of lower quality of sleep.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Insomnia Severity Index (ISI)
The ISI is a 7-item measure designed to briefly assess the severity of both nighttime and daytime insomnia symptoms. Responses will vary from Not at all (scored as 0) to Very Much (score as 4). Higher scores being indicative of increasing level of insomnia.
Measured: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Demographics Survey
Demographics and Health Questionnaires has questions pertinent to this research effort, including: age, sex, relationship status, race/ethnicity, education, military service, deployment history, health history, current and prior treatments.
Measured: Taken at Baseline to create comparable groups of treatment and will be used as covariates in statistical analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 May 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Oluwaseyi Gbade-Alabi, MD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214949
- Sponsor's protocol ID
- 2020-0324
- Acronym
- PrTMS
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) as a Treatment for Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06214949
- Acronym / sponsor ID
- PrTMS / 2020-0324
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Jan 2024 (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.
This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.
Detailed description
The objective of our proposed research is to (a) assess the efficacy of PrTMS therapy in reducing pain for military health system beneficiaries with chronic neck pain receiving standard of care* at Walter Reed National Military Medical Center, and (b) to describe participants' perceptions of PrTMS treatment and its perceived effect on their pain.
The specific aims for this study are as follows:
Specific Aims
Aim 1a: To assess the efficacy of PrTMS therapy in reducing pain for military health system beneficiaries with chronic neck pain receiving standard of care at Walter Reed National Military Medical Center.
Aim 1b: To describe participants' perceptions of PrTMS treatment and its perceived effect on their pain.
Hypothesis 1a: Participants receiving PrTMS therapy in addition to standard of care will report a significant mean reduction in their pain based on quantitative and qualitative assessments, when compared to standard of care plus sham PrTMS.
Hypothesis 1b: Participant response to PrTMS will be independent of patient demographics (age, race, sex), length of chronic pain, characterization of type of pain (e.g., sharp, burning, aching, etc.), or location of pain (e.g., local vs. radiating).
Outcome Measures:
DVPRS summary pain score and four supplemental questions, measuring activity, sleep, mood, and stress.
Aim 2: To examine the short- and intermediate-term changes in self-reported quality of life and biopsychosocial symptoms related to pain in military health system beneficiaries receiving PrTMS in addition to standard of care for chronic neck pain at Walter Reed National Military Medical Center.
Hypothesis 2: Participants receiving PrTMS therapy will report significantly lower mean scores on PROMIS (fatigue, pain interference, and social isolation) and sleep disturbance, and higher mean PROMIS (physical function and satisfaction with social roles) than participants receiving sham PrTMS across the intervention period and at follow up.
Outcome Measures:
The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) measures are validated, global measures of patient-reported outcomes with standardized scales and computer adaptive testing (CAT). CAT allows for reduced participant burden, as the number of questions asked to arrive at a score are fewer. PROMIS measures have also been recommended as an assessment tool for studies conducted exploring TMS as treatment for pain. To measure the biopsychosocial elements of pain, the following PROMIS measures will be utilized:
- PROMIS Bank v1.0 - Fatigue
- PROMIS Bank v1.1 - Pain Interference
- PROMIS Bank v2.0 - Physical Function
- PROMIS Bank v2.0 - Satisfaction with Social Roles
- PROMIS Bank v1.0 - Social Isolation
Aim 3: To assess the impact that confounding factors such as depression, anxiety, sleep disorders, or PTSD may have on the efficacy of PrTMS as an augmentation to standard of care.
Hypothesis 3: Participants that have high premorbid levels of mental health disease or sleep disturbances will exhibit less response to PrTMS than those who do not.
Outcome Measures:
PCL-5, PHQ-9, SCI, GAD-7 and OURA ring. (see section 10.2)
Aim 4: To assess the short- and intermediate-term changes in plasma neuropeptides, inflammatory proteins and nucleic acids that can serve as blood based biomarkers for pain /stress.
Hypothesis 4: Participants receiving PrTMS therapy will demonstrate significantly lower mean plasma concentrations of tested plasma neuropeptides and inflammatory proteins, as well as associated genetic markers, including mRNA, miRNA, and genomic sequences.
Biological Blood and Serum Measures:
Neuropeptides such as ACTH, NPY, IGF-1, BDNF, NSE, GFAP, S100B; inflammatory proteins, such as IL-1beta, IL-2, IL-6, IL-8, IL-10, IL-12, TNF-alpha, IFN-gamma, MCP1/CCL2, CRP; mRNA; miRNA; and whole genome sequencing (WGS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Repetitive Transcranial Magnetic Stimulation | Experimental | Device: Personalized Repetitive Transcranial Magnetic Stimulation |
| Sham Personalized Repetitive Transcranial Magnetic Stimulation | Experimental | Device: Sham Personalized Repetitive Transcranial Magnetic Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Military health care beneficiary for enrollment.
- Over the age of 18 years.
- Presence of chronic neck pain for at least 3 months.
Key exclusion criteria (16 listed)
- History of seizure, bipolar disorder, or schizophrenia.
- Unstable heart or pulmonary disease.
- Brain tumor, active brain infection, history of cerebral vascular accident (CVA), or penetrating brain injury.
- Use of medications that potentially lower seizure threshold without concomitant administration of anticonvulsant drugs that may protect against seizure occurrence.
- Not a suitable candidate for the study as determined by the PI.
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 |
|---|---|---|
| Personalized Repetitive Transcranial Magnetic StimulationTreatment will consist of 15 sessions over 3-4 weeks. Specifically, the active or sham treatments will be conducted ~5 times a week during the treatment phase of the study. The treatment protocol parameters (stimulus location, frequency, duration, and intensity) will be derived from the PrTMS software algorithm which incorporates clinical inputs from neurocognitive surveys and quantitative EEG analysis. The mechanical parameters will adhere to the recommended PrTMS parameters for pain treatment: figure of 8 coil that produces biphasic stimulatory pulses to the central zone cortex, frontal zone cortex, Broca's area, and frontal pre-cortex areas at a stimulation depth of 2 cm. Treatment parameters will be unique to each participant but will remain within known ranges. The frequency will be between 8 and 13 Hz, at an amplitude of 20-30% (approximately 30-40% of RMT), and about 3200-7200 pulses per session. Since parameters are specific to each participant, treatment settings will vary. | Device | Personalized Repetitive Transcranial Magnetic Stimulation |
| Sham Personalized Repetitive Transcranial Magnetic StimulationTreatment will consist of 15 sessions over the course of 3-4 weeks. More specifically, the active or sham treatments will be conducted roughly 5 times a week during the course of the treatment phase of the study. The TMS system will have three coils, one designated active and the other two unlabeled and identical in appearance, weight, and noises emitted, one of which will be active and one of which will be sham. | Device | Sham Personalized Repetitive Transcranial Magnetic Stimulation |
Primary outcome
Defense & Veterans Pain Rating Scale (DVPRS)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements taken everyday during Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
The DVPRS was developed to standardize pain measurement across all health care settings and promote pain assessment and reassessment practices. DVPRS is a visual pain scale to assess individual's pain intensity on a scale of 0-10, with an additional 4 questions to assess pain's interference with the participant's activity, sleep, mood, and stress. The scale has excellent internal reliability and test-retest reliability.
13 secondary outcomes
Patient Global Impression of Change (PGIC)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
TMS Tolerability Worksheet (TTW)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Pain Anxiety Symptom Scale Short Form 20 (PASS)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Sleep Condition Indicator (SCI)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Patient Health Questionnaire (PHQ-9)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Quantitative Analgesic Questionnaire (QAQ)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Suicide Behaviors Questionnaire-Revised (SBQ-R)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Patient Reported Outcomes Measurement Information System (PROMIS) Scales.
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Insomnia Severity Index (ISI)
Time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
Demographics Survey
Time frame: Taken at Baseline to create comparable groups of treatment and will be used as covariates in statistical analysis.
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 6 Mar 2025.
Related trials for Neck Pain
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Recruiting
Kinesiology Taping Versus Self-Mobilization for Neck Pain Related to Prolonged Electronic Device Use
Neck Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
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.
Oluwaseyi Gbade-Alabi, MD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Repetitive Transcranial Magnetic Stimulation in people with Neck Pain, run by Henry M. Jackson Foundation for the Advancement of Military Medicine 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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. 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.
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 Oluwaseyi Gbade-Alabi, MD (240-688-7145, oluwaseyi.gbade-alabi@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defense & Veterans Pain Rating Scale (DVPRS) (time frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements taken everyday during Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up). 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 6 Mar 2025.