Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04203199
Status:
TERMINATED
Last Update Posted:
2023-09-15
First Post:
2019-12-16
Brief Title:
H-coil TMS to Reduce Pain A Pilot Study Evaluating Relative Efficacy of the H1 vs H7 Coil
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
H-coil TMS to Reduce Pain A Pilot Study Evaluating Relative Efficacy of the H1 vs H7 Coil
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic pain is a serious public health problem with estimates as high as nearly half of the adult population experiencing some form of pain that lasts for more than 6 months Chronic use of opiates is a rapidly escalating crisis in the United States with over 43 million Americans dependent on opiate analgesics an escalating rate of opiate overdose deaths and a resurgence of intravenous heroin use leading to total societal cost exceeding 55 billion While opiates are effective at treating acute pain tolerance to the analgesic effects develops quickly leading to high abuse liability and dependence potential Consequently the development of a new non-pharmacologic intervention to treat pain such as repetitive transcranial magnetic stimulation rTMS which would provide analgesic benefit while also directly remodeling the neural circuitry responsible for cognitive control over opiate craving would fill an increasingly urgent public health need
Detailed Description:
Chronic pain is a serious public health problem with estimates as high as nearly half of the adult population experiencing some form of pain that lasts for more than 6 months Chronic use of opiates is a rapidly escalating crisis in the United States with over 43 million Americans dependent on opiate analgesics an escalating rate of opiate overdose deaths and a resurgence of intravenous heroin use leading to total societal cost exceeding 55 billion While opiates are effective at treating acute pain tolerance to the analgesic effects develops quickly leading to high abuse liability and dependence potential Consequently the development of a new non-pharmacologic intervention to treat pain such as repetitive transcranial magnetic stimulation rTMS which would provide analgesic benefit while also directly remodeling the neural circuitry responsible for cognitive control over opiate craving would fill an increasingly urgent public health need
Acute pain is associated with elevated magnetic resonance imaging MRI blood-oxygen-level-dependent BOLD signal in targets of ascending nociceptive fibers including the insula dorsal anterior cingulate dACC thalamus and somatosensory cortex - the Pain Network Perceived pain and corresponding BOLD signal in the Pain Network is attenuated by 10 Hz rTMS a form of brain stimulation that results in long term potentiation LTP to the left dorsolateral prefrontal cortex dlPFC a node of the Executive Control Network Dr Borckardt was the first person to demonstrate that when LTP-like dlPFC rTMS was delivered in the postoperative recovery room patients used less morphine in the hospital and require less morphine long-term These analgesic effects are now widely known with over 33 clinical trials utilizing rTMS as a tool to decrease acute and chronic pain in various clinical populations
These data all suggest that LTP-like DLPFC rTMS is a very strong candidate alleviating chronic pain LTP-like dlPFC rTMS Strategy 1 Aim 1 An alternative approach however which may also target opiate craving is to attenuate the Pain Network through long term depression LTD of the ventromedial PFC LTD-like mPFC rTMS Strategy 2 Aim 1 In a cohort of 49 individuals with chronic pain Dr Hanlon Primary Investigator recently demonstrated that LTD-like mPFC rTMS reduced baseline BOLD signal in multiple regions of interest ROIs involved in craving which also overlap with the Pain Network eg dACC and Insula To parametrically evaluate these 2 promising treatment strategies the investigator has developed a 1-visit cross-sectional design wherein a cohort of healthy control individuals will receive Quantitative Sensory Testing before and after rTMS with the H1 and H7-coil for dlPFC stimulation Strategy 1 and mPFC depression Strategy 2 respectively The investigator aims to
Aim 1 Quantify the effects of LTP-like and LTD-like RTMS on Quantitative Sensory Testing Hypothesis The pressure pain tolerance of individuals in these two groups will increase after one session of rTMS administered by the H1- and H7-coil design
Aim 2 Evaluate the effects of rTMS on subjective experience of discomfort Hypothesis Subjective experience of discomfort will decrease in individuals after one session of LTP-like or LTD-like rTMS administered to the dlPFC and mPFC respectively
The relative efficacy of Strategy 1 vs 2 will directly translate to development of a large clinical trial of rTMS as an innovative new treatment option for pain in opiate dependent individuals
Acute pain is associated with elevated magnetic resonance imaging MRI blood-oxygen-level-dependent BOLD signal in targets of ascending nociceptive fibers including the insula dorsal anterior cingulate dACC thalamus and somatosensory cortex - the Pain Network Perceived pain and corresponding BOLD signal in the Pain Network is attenuated by 10 Hz rTMS a form of brain stimulation that results in long term potentiation LTP to the left dorsolateral prefrontal cortex dlPFC a node of the Executive Control Network Dr Borckardt was the first person to demonstrate that when LTP-like dlPFC rTMS was delivered in the postoperative recovery room patients used less morphine in the hospital and require less morphine long-term These analgesic effects are now widely known with over 33 clinical trials utilizing rTMS as a tool to decrease acute and chronic pain in various clinical populations
These data all suggest that LTP-like DLPFC rTMS is a very strong candidate alleviating chronic pain LTP-like dlPFC rTMS Strategy 1 Aim 1 An alternative approach however which may also target opiate craving is to attenuate the Pain Network through long term depression LTD of the ventromedial PFC LTD-like mPFC rTMS Strategy 2 Aim 1 In a cohort of 49 individuals with chronic pain Dr Hanlon Primary Investigator recently demonstrated that LTD-like mPFC rTMS reduced baseline BOLD signal in multiple regions of interest ROIs involved in craving which also overlap with the Pain Network eg dACC and Insula To parametrically evaluate these 2 promising treatment strategies the investigator has developed a 1-visit cross-sectional design wherein a cohort of healthy control individuals will receive Quantitative Sensory Testing before and after rTMS with the H1 and H7-coil for dlPFC stimulation Strategy 1 and mPFC depression Strategy 2 respectively The investigator aims to
Aim 1 Quantify the effects of LTP-like and LTD-like RTMS on Quantitative Sensory Testing Hypothesis The pressure pain tolerance of individuals in these two groups will increase after one session of rTMS administered by the H1- and H7-coil design
Aim 2 Evaluate the effects of rTMS on subjective experience of discomfort Hypothesis Subjective experience of discomfort will decrease in individuals after one session of LTP-like or LTD-like rTMS administered to the dlPFC and mPFC respectively
The relative efficacy of Strategy 1 vs 2 will directly translate to development of a large clinical trial of rTMS as an innovative new treatment option for pain in opiate dependent individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None