Assessment of Prepulse Inhibition for Shock Pain Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193986
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 14, 2006
Dr. Douglas Cameron
St. Jude Medical
Information provided by:
University Health Network, Toronto

Brief Summary:

Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's) is highly variable. It can be influenced by psychological factors, physical condition and the number of shocks delivered.

It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low voltage pulse (prepulse)prior to the delivery of a stronger shock.

A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a shock of equal energy without a prepulse.

Condition or disease Intervention/treatment Phase
Pain Awareness From ICD Shocks Device: Arbitrary Waveform Defibrillator Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Assessment of Prepulse Inhibition for Shock Pain Reduction- Ventricular
Study Start Date : May 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

18+ Approved indication for implantation of an ICD Able and willing to provide informed consent Independently complete and understand the Mini Mental State Evaluation

Exclusion Criteria:

Pregnancy Cannot understand English or French Contraindicated for defibrillation testing because of risk of thromboembolism Deaf or hard of hearing, making the acute testing difficult to conduct having pain or anxiety to the extent that, in the opinion of the investigator, the results would be confounded.

Having a Class I bradycardia pacing indication, requiring ongoing pacing support.

Visual problems which preclude reading the computer screen for the VAS test Severe musculoskeletal disorder that makes it difficult to undergo testing in the recumbent position Do not achieve a score >24/30 on a Mini Mental State Exam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193986

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Dr. Douglas Cameron
St. Jude Medical
Principal Investigator: Douglas A Cameron, MD UHN Identifier: NCT00193986     History of Changes
Other Study ID Numbers: 04-0252-B
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: November 14, 2006
Last Verified: September 2006

Keywords provided by University Health Network, Toronto:

Additional relevant MeSH terms:
Pathologic Processes