TMS Treatment for Pain in Chronic Pancreatitis

NCT00250484 | Completed Results DMC

• 2 other identifiers: 2005P-000259 DK71851R03DK071851
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Chronic Pancreatitis; Pain

Keywords

analgesia; electric stimulation therapy; electric stimulation; pain; safety

Outcome Measures

Primary Outcomes (1)

• Pain (Visual Analog Scale, CGI, PGA)

  Pain intensity and therefore changes in pain intensity were assessed using a 0-10 Visual Analog Scale where 0 represents the least amount of pain and 10 is the most pain imaginable. The pain evaluation was carried out by a blinded rater based off 1) baseline evaluation: 3 week long pain logs and a diary of pain medication intake, 2) treatment evaluations: participants were also asked to fill out daily pain logs following each TMS session and to keep a diary of pain medications during the CRC stay for the TMS course and 3)follow-up evaluation: finally, there was a follow up measurement 3 weeks after treatment.

  1 year

Secondary Outcomes (2)

• Cognitive Assessment - Neuropsychological Battery

  Baseline and end of treatment at approximately 1 year

• Medication Use (Medication Diary)

  Baseline and end of treatment at approximately 1 year

Study Arms (2)

Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

Active treatment with TMS for 10 days.

Device: Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

SHAM COMPARATOR

Patients will receive no active TMS/treatment.

Device: Sham Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day

Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation DEVICE

Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day

Sham 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:

• Patients will be eligible if:
• They are age 18 years or older They have daily abdominal pain for at least three months attributed to their chronic pancreatitis Average pain scores (VAS) in the baseline period higher than 4.
• The diagnosis of chronic pancreatitis will be based on the existence of chronic abdominal pain and at least one of the four following criteria:
• Calcifications throughout the pancreas on plain abdominal radiograph. Endoscopically derived pancreatogram showing ductal changes consistent with chronic pancreatitis.
• Abnormal secretin pancreatic function test with a peak bicarbonate level of less than 70 mEq/L (normal being \>80 mEq/L).
• Tissue diagnosis of chronic pancreatitis from a surgical specimen.

You may not qualify if:

• Other causes of chronic pancreatitis will be excluded as follows:
• Hereditary pancreatitis based on genetic mutations or a family history of pancreatitis; Alcohol abuse (the criteria for "at risk" \[heavy\] drinking established by the National Institute on Alcohol Abuse and Alcoholism \[NIAAA\], which suggest that the person is at risk for adverse consequences, are greater than 14 drinks per week or 4 drinks per occasion for men, and greater than 7 drinks per week or 3 drinks per occasion for women);
• Medications associated with the development of pancreatitis (e.g. valproic acid, metronidazole, tetracycline, sulfonamides, nitrofurantoin, azathioprine, pentamidine), trauma, metabolic causes including hyperlipidemia and hypercalcemia, and autoimmune pancreatitis.
• Participants will be excluded if there are known complications of chronic pancreatitis requiring interventions including pseudocysts or pancreatic duct obstruction or if there is the presence of cancer.
• Patients with a clinical diagnosis of severe depression including suicidal ideation; Prior neurosurgical procedure; Past history of epilepsy or family history of epilepsy; Previous head injury; Metal located in the head, i.e. shrapnel, surgical clips, or fragments from welding; Signs of increased intracranial pressure; Stroke; Chronic treatment with epileptogenic medications; Abnormal neurological examination other than as signs of the condition studied in the present protocol; Implanted pacemaker; Medication pump; Vagal stimulator; Deep brain stimulator; Transcutaneous electrical stimulation (TENS) unit and ventriculo-peritoneal shunt; Pregnancy; Other chronic medical conditions and history of substance abuse; History of medical and surgical therapies for pain within 3 months.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Steven D. Freedman, MD Phd
• Organization: Beth Israel Deaconess

sfreedma@bidmc.harvard.edu

631-667-2132

Study Officials

• Steven D Freedman, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Professor Medicine Harvard Medical School

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 11, 2017
• Results First Posted: October 21, 2016

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)