search
Back to results

Transcranial Magnetic Stimulation for the Treatment of Phantom Pain

Primary Purpose

Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Amputee, Phantom Limb, Amputation, Magnetic Stimulation, Phantom

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001923
Brief Title
Transcranial Magnetic Stimulation for the Treatment of Phantom Pain
Official Title
Phantom Pain: A Therapeutic Trial Using Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain, Amputee, Phantom Limb, Amputation, Magnetic Stimulation, Phantom

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Transcranial magnetic stimulation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7884476
Citation
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.
Results Reference
background
PubMed Identifier
8758953
Citation
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.
Results Reference
background
PubMed Identifier
9469535
Citation
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.
Results Reference
background

Learn more about this trial

Transcranial Magnetic Stimulation for the Treatment of Phantom Pain

We'll reach out to this number within 24 hrs