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Transcranial Magnetic Stimulation for the Treatment of Phantom Pain

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001923
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: December 2002
  Purpose

Phantom pain refers to the sensation of pain felt by patients who have had a limb amputated. The treatment of phantom pain is often disappointing and is unable to provide adequate relief to the patients. The area of the brain involved (posterior parietal cortex [PPC]) is found on the opposite side of the amputated limb. For example, if a patient has the right arm amputated, the left posterior parietal cortex is involved in the phantom pain.

Researchers believe that if they can decrease activity in the posterior parietal cortex they may be able to reduce phantom pain.

Researchers plan to use low frequency (1 Hz) transcranial magnetic stimulation (TMS) to decrease the excitability of the PPC opposite the side of the amputated limb. TMS involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and turning on the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). When an area of the brain is stimulated a period follows when that area cannot be stimulated again. In this case, researchers plan to use TMS to stimulate the PPC in order to decrease the level of excitability there.


Condition Intervention Phase
Pain
Procedure: Transcranial magnetic stimulation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Phantom Pain: A Therapeutic Trial Using Transcranial Magnetic Stimulation

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 20
Study Start Date: December 1998
Estimated Study Completion Date: December 2002
Detailed Description:

Phantom pain is a chronic painful condition that affects patients with amputations. Treatment for phantom pain is often disappointing. In amputees, hyperexcitability of the posterior parietal cortex area (PPC) contralateral to the side of the amputation has been linked with the presence of phantom sensations. PPC is an area overactive in different forms of chronic pain too. It is therefore conceivable that downregulation of activity in PPC could improve phantom limb pain, a condition poorly responsive to available treatments. We have previously demonstrated that low frequency TMS (1 Hz) results in decreased excitability of the stimulated cortical regions. We plan to apply low-frequency TMS to PPC cortical areas contralateral to the side of the amputated limb. We expect that this intervention will result in amelioration of the phantom pain. Stimulation of the PPC area (target intervention) will be compared with a control intervention in which TMS is directed slightly away from the head.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients must be between 18 and 65 years of age.

Patients must have amputations and phantom pain for at least 12 months.

Patient's pain should be at least moderate and be present at least 8 hours per day or severe lasting for at least 2 hours per day.

Patients must not have had a previous stroke or brain lesions.

Patients must not have severe depression, poor motivational capacity.

Patients must not have serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less).

Patients must not have severe uncontrolled medical problems (e.g. cardiovascular disease, any kind of end-stage pulmonary or cardiovascular disease, or epilepsy).

Patients must not have a personal history of seizures or other neurological disorders.

Women must not be pregnant.

Patients must not have severe coronary disease.

Patients must not have metal in the cranium except mouth.

Patients must not have intracardiac lines.

Patients must not have increased intracranial pressure as evaluated by clinical means.

Patients must not have cardiac pacemakers.

Patients must not be taking neuroleptics.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00001923

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001923     History of Changes
Other Study ID Numbers: 990022, 99-N-0022
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pain
Amputee
Phantom Limb
Amputation
Magnetic Stimulation
Phantom

Additional relevant MeSH terms:
Phantom Limb
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pain
Pain, Postoperative
Pathologic Processes
Perceptual Disorders
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014