Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)

NCT ID: NCT06214949

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Personalized Repetitive Transcranial Magnetic Stimulation

Group Type: EXPERIMENTAL

Personalized Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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 Stimulation

Group Type: EXPERIMENTAL

Sham Personalized Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Military health care beneficiary for enrollment.
• Over the age of 18 years.
• Presence of chronic neck pain for at least 3 months.

Exclusion Criteria

• 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.

1. Antiviral medications and antipsychotic medications

2. Recent withdrawal from sedatives

3. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oluwaseyi Gbade-Alabi, MD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Oluwaseyi Gbade-Alabi, MD

Role: CONTACT

oluwaseyi.gbade-alabi@usuhs.edu

240-688-7145

Miana F Atkins, MPH

Role: CONTACT

CRSR_Research@usuhs.edu

240-688-7145

Facility Contacts

Oluwaseyi Gbade-Alabi, MD

Role: primary

oluwaseyi.gbade-alabi@usuhs.edu

240-688-7145

Miana Atkins, MPH

Role: backup

CRSR_Research@usuhs.edu

240-688-7145

Other Identifiers

2020-0324

Identifier Type: -

Identifier Source: org_study_id