Transcranial Magnetic Stimulation for the Treatment of Phantom Pain
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||December 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001923 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Transcranial Magnetic Stimulation for the Treatment of Phantom Pain|
|Official Title ICMJE||Phantom Pain: A Therapeutic Trial Using Transcranial Magnetic Stimulation|
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.
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 Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Intervention ICMJE||Procedure: Transcranial magnetic stimulation|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2002|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001923|
|Other Study ID Numbers ICMJE||990022, 99-N-0022|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP