Transcranial Magnetic Stimulation for the Treatment of Phantom Pain

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
Overall Status
Completed
CT.gov ID
NCT00001923
Collaborator
(none)
20
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Transcranial magnetic stimulation
Phase 1

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phantom Pain: A Therapeutic Trial Using Transcranial Magnetic Stimulation
Study Start Date :
Dec 1, 1998
Study Completion Date :
Dec 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00001923
    Other Study ID Numbers:
    • 990022
    • 99-N-0022
    First Posted:
    Nov 4, 1999
    Last Update Posted:
    Mar 4, 2008
    Last Verified:
    Dec 1, 2002
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 4, 2008