Transcranial Magnetic Stimulation for the Treatment of Phantom Pain

NCT00001923 | Completed Phase 1

• 2 other identifiers: 99002299-N-0022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Amputee; Phantom Limb; Amputation; Magnetic Stimulation; Phantom

Interventions

Transcranial magnetic stimulation PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kew JJ, Ridding MC, Rothwell JC, Passingham RE, Leigh PN, Sooriakumaran S, Frackowiak RS, Brooks DJ. Reorganization of cortical blood flow and transcranial magnetic stimulation maps in human subjects after upper limb amputation. J Neurophysiol. 1994 Nov;72(5):2517-24. doi: 10.1152/jn.1994.72.5.2517.

  PMID: 7884476 BACKGROUND

• Vogt BA, Derbyshire S, Jones AK. Pain processing in four regions of human cingulate cortex localized with co-registered PET and MR imaging. Eur J Neurosci. 1996 Jul;8(7):1461-73. doi: 10.1111/j.1460-9568.1996.tb01608.x.

  PMID: 8758953 BACKGROUND

• Derbyshire SWG, Jones AKP, Gyulai F, Clark S, Townsend D, Firestone LL. Pain processing during three levels of noxious stimulation produces differential patterns of central activity. Pain. 1997 Dec;73(3):431-445. doi: 10.1016/S0304-3959(97)00138-3.

  PMID: 9469535 BACKGROUND

MeSH Terms

Conditions

Pain; Phantom Limb

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: December 1, 1998
• Study Completion: December 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-12

Locations

US (1)