NCT06214949

Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)

Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) as a Treatment for Chronic Neck Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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: 1. PROMIS Bank v1.0 - Fatigue 2. PROMIS Bank v1.1 - Pain Interference 3. PROMIS Bank v2.0 - Physical Function 4. PROMIS Bank v2.0 - Satisfaction with Social Roles 5. 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

Interventions

Type	Name	Description
DEVICE	Personalized Repetitive Transcranial Magnetic Stimulation	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.
DEVICE	Sham Personalized Repetitive Transcranial Magnetic Stimulation	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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2024-01-22
• Last updated: 2025-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study