Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250484
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2005-11-07
Brief Title:
TMS Treatment for Pain in Chronic Pancreatitis
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
The Effect of 10-Day Treatment of Repetitive Transcranial Magnetic Stimulation on Abdominal Pain in Patients With Chronic Pancreatitis
Status:
COMPLETED
Status Verified Date:
2017-09
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:
None
Brief Summary:
The researchers aim to study the effects of repetitive transcranial magnetic stimulation rTMS on chronic visceral pain in patients with idiopathic chronic pancreatitis
Detailed Description:
The purpose of this protocol is to investigate a possible novel treatment for intractable visceral pain in patients with chronic pancreatitis Pain is a major contributor to the poor quality of life in patients with chronic pancreatitis The refractory nature of this condition to medical and surgical procedures prompted us to hypothesize that one mechanism leading to pain in these patients is the dysfunction of brain cortical regulation of visceral sensation This notion is particularly supported by findings that patients with chronic pancreatitis can continue to experience disabling pain even after total pancreatectomy This suggests that symptoms are sustained by a pancreas-independent neural-based mechanism Visceral sensation is particularly processed in the secondary somatosensory area - SII Therefore chronic pancreatitis pain may be sustained by a dysfunction of SII rather than by pancreatic inflammation alone The researchers hypothesize further that the dysfunction of SII is one of hyper-excitability According to this hypothesis suppression of SII activity may help control the pain in patients with chronic pancreatitis Temporary inhibition of SII activity can be obtained by a novel tool namely transcranial magnetic stimulation TMS which can suppress brain excitability non-invasively beyond the duration of the TMS if appropriate stimulation parameters are employed In the initial sham controlled double blind pilot trial of 5 subjects with idiopathic chronic pancreatitis TMS applied to SII resulted in significant pain improvement in 3 of the subjects The researchers will rigorously test the hypothesis that chronic pancreatitis pain is sustained by a dysfunction of SII characterized by hyperexcitability through two specific aims
1 The first aim of this study is to examine whether slow repetitive TMS rTMS applied to SII in patients with pain and chronic pancreatitis has an analgesic effect as measured by changes in the Visual Analogue Scale VAS for pain and a decrease in analgesic intake as well as an overall improvement in quality of life In addition if this study finds a significant effect of rTMS on pain reduction the duration of this effect will be further assessed TMS will be applied at parameters of stimulation known to decrease excitability
2 The second aim of the study is to assess the safety of rTMS in this patient population In the pilot study none of the patients experienced any adverse effects of a single session of rTMS However the extension of the study protocol to a 10-day course of daily rTMS requires careful safety assessment Fifteen-day courses of rTMS have been used for treatment of various neuropsychiatric diseases without any complications if safety guidelines are carefully followed The researchers will adhere to the current safety recommendations for rTMS endorsed by the International Society for Transcranial Stimulation and the International Federation for Clinical Neurophysiology Therefore the researchers hypothesize that the proposed rTMS protocol will be safe for the patient population
3 The third aim of the study is to study the physiologic mechanism of action of rTMS in these patients using magnetic resonance imaging MRI In doing so the researchers aim to contribute to a better understanding of the pathophysiology of chronic pain in patients with pancreatitis by investigating the correlation between pain improvement and areas of brain activation This could lead to the development of markers of therapeutic response Magnetic resonance spectroscopy allows a non-invasive measure of GABAergic and glutamatergic activity in a defined volume of interest in the brain The researchers hypothesize that the balance of GABA and glutamate will be abnormal in SII in patients with pain from chronic pancreatitis with a relative decrease in GABA and increase in glutamate indicating an abnormal hyperexcitable dysfunction This abnormality will be normalized by rTMS in correlation with its analgesic effect
1 The first aim of this study is to examine whether slow repetitive TMS rTMS applied to SII in patients with pain and chronic pancreatitis has an analgesic effect as measured by changes in the Visual Analogue Scale VAS for pain and a decrease in analgesic intake as well as an overall improvement in quality of life In addition if this study finds a significant effect of rTMS on pain reduction the duration of this effect will be further assessed TMS will be applied at parameters of stimulation known to decrease excitability
2 The second aim of the study is to assess the safety of rTMS in this patient population In the pilot study none of the patients experienced any adverse effects of a single session of rTMS However the extension of the study protocol to a 10-day course of daily rTMS requires careful safety assessment Fifteen-day courses of rTMS have been used for treatment of various neuropsychiatric diseases without any complications if safety guidelines are carefully followed The researchers will adhere to the current safety recommendations for rTMS endorsed by the International Society for Transcranial Stimulation and the International Federation for Clinical Neurophysiology Therefore the researchers hypothesize that the proposed rTMS protocol will be safe for the patient population
3 The third aim of the study is to study the physiologic mechanism of action of rTMS in these patients using magnetic resonance imaging MRI In doing so the researchers aim to contribute to a better understanding of the pathophysiology of chronic pain in patients with pancreatitis by investigating the correlation between pain improvement and areas of brain activation This could lead to the development of markers of therapeutic response Magnetic resonance spectroscopy allows a non-invasive measure of GABAergic and glutamatergic activity in a defined volume of interest in the brain The researchers hypothesize that the balance of GABA and glutamate will be abnormal in SII in patients with pain from chronic pancreatitis with a relative decrease in GABA and increase in glutamate indicating an abnormal hyperexcitable dysfunction This abnormality will be normalized by rTMS in correlation with its analgesic effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03DK071851 | NIH | None | httpsreporternihgovquickSearchR03DK071851 |