Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214949
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-12-19
Brief Title:
Personalized Repetitive Transcranial Magnetic Stimulation PrTMS
Sponsor:
Henry M Jackson Foundation for the Advancement of Military Medicine
Organization:
Henry M Jackson Foundation for the Advancement of Military Medicine
Study Overview
Official Title:
Personalized Repetitive Transcranial Magnetic Stimulation PrTMS as a Treatment for Chronic Neck Pain
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrTMS
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 eg sharp burning aching etc or location of pain eg 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 v10 - Fatigue
2 PROMIS Bank v11 - Pain Interference
3 PROMIS Bank v20 - Physical Function
4 PROMIS Bank v20 - Satisfaction with Social Roles
5 PROMIS Bank v10 - 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 102
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 MCP1CCL2 CRP mRNA miRNA and whole genome sequencing WGS
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 eg sharp burning aching etc or location of pain eg 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 v10 - Fatigue
2 PROMIS Bank v11 - Pain Interference
3 PROMIS Bank v20 - Physical Function
4 PROMIS Bank v20 - Satisfaction with Social Roles
5 PROMIS Bank v10 - 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 102
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 MCP1CCL2 CRP mRNA miRNA and whole genome sequencing WGS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None