RECRUITING

Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.

Official Title

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

Quick Facts

Study Start:2024-04-23

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06214949

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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.

Contacts and Locations

Study Contact

Daniel A Williams, B.A.

CONTACT

240-688-7145

CRSR_Research@usuhs.edu

Oluwaseyi Gbade-Alabi, MD

CONTACT

oluwaseyi.gbade-alabi@usuhs.edu

Principal Investigator

Oluwaseyi Gbade-Alabi, MD

PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Study Locations (Sites)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889

United States

Collaborators and Investigators

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Oluwaseyi Gbade-Alabi, MD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-23

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-04-23

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Neck Pain