Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)

NCT06214949 | Recruiting FDA Device

• 1 other identifier: 2020-0324
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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 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)

  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)

  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)

  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)

  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)

  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

Study Arms (2)

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

Interventions

Personalized Repetitive Transcranial Magnetic Stimulation 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.

Personalized Repetitive Transcranial Magnetic Stimulation

Sham Personalized Repetitive Transcranial Magnetic Stimulation 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.

Sham Personalized Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oluwaseyi Gbade-Alabi, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluwaseyi Gbade-Alabi, MD

CONTACT

240-688-7145; oluwaseyi.gbade-alabi@usuhs.edu

Miana F Atkins, MPH

CONTACT

240-688-7145; CRSR_Research@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 22, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

US (1)