PainPhase 1NCT00001923
Transcranial Magnetic Stimulation for the Treatment of Phantom Pain
A Phase 1 study testing Transcranial magnetic stimulation in people with Pain, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1998to Dec 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Transcranial magnetic stimulation
- Keywords
- Pain, Amputee, Phantom Limb, Amputation, Magnetic Stimulation, Phantom
- Medical subject headings
- Pain, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startDec 1998
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001923
- Sponsor's protocol ID
- 990022
- Other IDs
- 99-N-0022
- Status last verified
- Dec 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 7884476Vogt 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.
PubMed 8758953Derbyshire 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.
PubMed 9469535
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phantom Pain: A Therapeutic Trial Using Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT00001923
- Acronym / sponsor ID
- 990022
- Conditions
- Pain
- Keywords
- Pain, Amputee, Phantom Limb, Amputation, Magnetic Stimulation, Phantom
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Dec 1998
- Study completion
- Dec 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7884476Kew 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.
- Background: PubMed 8758953Vogt 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.
- Background: PubMed 9469535Derbyshire 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial magnetic stimulation in people with Pain, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001923, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.