Phantom Limb PainNCT02051959

Long-term Effects of Transcranial Direct Current Stimulation (tDCS) on Patients With Phantom Limb Pain (PLP)

A study of Phantom Limb Pain, run by Sheba Medical Center at 1 site in Israel.

Suspended

Paused. Enrolment is on hold for now and may resume.

Trial summary

Phantom limb pain (PLP) refers to pain in a limb that has been amputated or deafferented. Phantom limb pain might be related to brain cortical plastic changes. The purpose of this study is to determine the efficacy of a series of transcranial direct current stimulation (tDCS) sessions, a non-invasive and focal brain… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Phantom Limb Pain
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteIsrael
Study dates: May 2015to Dec 2017
Phase: Interventional
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 80
Limb amputation from at least 6 months before study enrollment
Presence of PLP at least 2 times a week and present 4 weeks prior to onset of study
Written informed consent

Who cannot join

Coexistence of major neurological or psychiatric diseases
Being actively enrolled in a separate study targeting pain relief
Post traumatic stress disorder (PTSD) diagnosed patients
Any contraindication to noninvasive brain stimulation such as past brain surgery, brain implants, cochlear implant, epilepsy or any past seizure
Pregnant women
Within the traumatic amputees group - subjects diagnosed with diabetes

Trial locations and contacts

1 site in 1 country.

Israel1 site

Department of Orthopedic Rehabilitation, Sheba Medical Center
Ramat Gan

Other trials in Israel

About this study

Official title: Long-Term Treatment of Patients Experiencing Phantom Limb Pain With Transcranial Direct Current Stimulation (tDCS)

Phantom limb pain (PLP) refers to pain in a limb that has been amputated or deafferented. Phantom limb pain might be related to brain cortical plastic changes.
The purpose of this study is to determine the efficacy of a series of transcranial direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation method, in producing long-term reduction of phantom limb pain among amputees who experience such pain.

This is a Crossover sham control.

Conditions: Phantom Limb Pain
Being tested: Anodal stimulation of M1 + sham, Sham + Anodal stimulation of M1, Cathodal stimulation of M1 + sham, Sham + Cathodal stimulation of M1
Keywords: Phantom Limb Pain, Transcranial Direct Current Stimulation, Amputation, Diabetes Mellitus
Medical subject headings: Phantom Limb, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anodal stimulation of M1 + shamDevice
Also called tDCS
8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.
Sham + Anodal stimulation of M1Device
Also called tDCS
8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).
Cathodal stimulation of M1 + shamDevice
Also called tDCS
8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.
Sham + Cathodal stimulation of M1Device
Also called tDCS
8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area).

Study groups in NCT02051959
Study group	Role	What they receive
Crossover 1a: anodal stimulation of M1 + sham	Active comparator	6 amputees will undergo 8 active treatments of 20 min 2mA anodal stimulation of M1 localized to the contralateral amputation area followed by 8 sham treatments. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: * EEG and pain measurements * 20 minutes of stimulation * EEG and pain measurements after completion of stimulation Receives: Device: Anodal stimulation of M1 + sham
Crossover 1b: sham + anodal stimulation of M1	Active comparator	6 amputees will undergo 8 sham treatments followed by 8 active treatments of 20 min 2mA anodal stimulation of M1 localized to the contralateral amputation area. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: * EEG and pain measurements * 20 minutes of stimulation * EEG and pain measurements after completion of stimulation Receives: Device: Sham + Anodal stimulation of M1
Crossover 2a: cathodal stimulation of M1 + sham	Active comparator	6 amputees will undergo 8 active treatments of 20 min 2mA cathodal stimulation of M1 localized to the contralateral amputation area followed by 8 sham treatments. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: * EEG and pain measurements * 20 minutes of stimulation * EEG and pain measurements after completion of stimulation Receives: Device: Cathodal stimulation of M1 + sham
Crossover 2b: sham + cathodal stimulation of M1	Active comparator	6 amputees will undergo 8 sham treatments followed by 8 active treatments of 20 min 2mA cathodal stimulation of M1 localized to the contralateral amputation area. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: * EEG and pain measurements * 20 minutes of stimulation * EEG and pain measurements after completion of stimulation Receives: Device: Sham + Cathodal stimulation of M1

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduced phantom limb pain
Reduction of phantom limb pain compared to phantom limb pain before treatment, according to Visual Analog Scales (VAS) evaluation
Measured: 5 months after last stimulation session

Secondary outcomes (2)

Adverse effects of treatment
Severity of any adverse effects related to the transcranial direct current stimulation treatment will be checked after each stimulation session
Measured: Up to 5 weeks
Effects of treatment on the electrical activity of the brain
Measurement of the electrical activity of the brain before, during and after each stimulation using an electroencephalography (EEG) device.
Measured: Up to 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Dec 2017

First posted31 Jan 2014 (estimated)
Study startMay 2015
Primary completionJun 2017 (estimated)
Study completionDec 2017 (estimated)

Why it stopped: Signing a contract with the company owning the equipment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Phantom Limb PainStudies of the same condition, open and under way.
More trials run by Sheba Medical CenterThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02051959
Sponsor's protocol ID: SHEBA-13-0733-IS-CTIL
Status last verified: Jan 2016
First submitted: 28 Jan 2014
Last updated: 27 Jan 2016
Results posted: No
Data monitoring committee: No

Publications

Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
PubMed 12849487
Cohen LG, Bandinelli S, Findley TW, Hallett M. Motor reorganization after upper limb amputation in man. A study with focal magnetic stimulation. Brain. 1991 Feb;114 ( Pt 1B):615-27. doi: 10.1093/brain/114.1.615.
PubMed 2004259
Lotze M, Flor H, Grodd W, Larbig W, Birbaumer N. Phantom movements and pain. An fMRI study in upper limb amputees. Brain. 2001 Nov;124(Pt 11):2268-77. doi: 10.1093/brain/124.11.2268.
PubMed 11673327
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
PubMed 17452283
Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
PubMed 14580622
Nuti C, Peyron R, Garcia-Larrea L, Brunon J, Laurent B, Sindou M, Mertens P. Motor cortex stimulation for refractory neuropathic pain: four year outcome and predictors of efficacy. Pain. 2005 Nov;118(1-2):43-52. doi: 10.1016/j.pain.2005.07.020. Epub 2005 Oct 7.
PubMed 16214292
Khedr EM, Ahmed MA, Fathy N, Rothwell JC. Therapeutic trial of repetitive transcranial magnetic stimulation after acute ischemic stroke. Neurology. 2005 Aug 9;65(3):466-8. doi: 10.1212/01.wnl.0000173067.84247.36.
PubMed 16087918
Bolognini N, Olgiati E, Maravita A, Ferraro F, Fregni F. Motor and parietal cortex stimulation for phantom limb pain and sensations. Pain. 2013 Aug;154(8):1274-80. doi: 10.1016/j.pain.2013.03.040. Epub 2013 Apr 19.
PubMed 23707312
Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547
O'Connell NE, Cossar J, Marston L, Wand BM, Bunce D, Moseley GL, De Souza LH. Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA. PLoS One. 2012;7(10):e47514. doi: 10.1371/journal.pone.0047514. Epub 2012 Oct 17.
PubMed 23082174
Nitsche MA, Liebetanz D, Antal A, Lang N, Tergau F, Paulus W. Modulation of cortical excitability by weak direct current stimulation--technical, safety and functional aspects. Suppl Clin Neurophysiol. 2003;56:255-76. doi: 10.1016/s1567-424x(09)70230-2. No abstract available.
PubMed 14677403
Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.
PubMed 16427357
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 7884476
Chen R, Corwell B, Yaseen Z, Hallett M, Cohen LG. Mechanisms of cortical reorganization in lower-limb amputees. J Neurosci. 1998 May 1;18(9):3443-50. doi: 10.1523/JNEUROSCI.18-09-03443.1998.
PubMed 9547251
Karl A, Birbaumer N, Lutzenberger W, Cohen LG, Flor H. Reorganization of motor and somatosensory cortex in upper extremity amputees with phantom limb pain. J Neurosci. 2001 May 15;21(10):3609-18. doi: 10.1523/JNEUROSCI.21-10-03609.2001.
PubMed 11331390

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Lower Limb Amputation
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee

All Phantom Limb Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Treatment of Patients Experiencing Phantom Limb Pain With Transcranial Direct Current Stimulation (tDCS)
ClinicalTrials.gov ID: NCT02051959
Acronym / sponsor ID: SHEBA-13-0733-IS-CTIL
Conditions: Phantom Limb Pain
Keywords: Phantom Limb Pain, Transcranial Direct Current Stimulation, Amputation, Diabetes Mellitus
Study type: Interventional
Recruitment status: SuspendedReason stopped: Signing a contract with the company owning the equipment
Enrolment: 24 participants (estimated)
Lead sponsor: Sheba Medical CenterOther government
Study start: May 2015
Primary completion: Jun 2017 (estimated)
Study completion: Dec 2017 (estimated)
First posted: 31 Jan 2014 (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 limb pain (PLP) refers to pain in a limb that has been amputated or deafferented. Phantom limb pain might be related to brain cortical plastic changes.
The purpose of this study is to determine the efficacy of a series of transcranial direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation method, in producing long-term reduction of phantom limb pain among amputees who experience such pain.

This is a Crossover sham control.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Crossover 1a: anodal stimulation of M1 + sham	Active comparator	Device: Anodal stimulation of M1 + sham6 amputees will undergo 8 active treatments of 20 min 2mA anodal stimulation of M1 localized to the contralateral amputation area followed by 8 sham treatments. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: * EEG and pain measurements * 20 minutes of stimulation * EEG and pain measurements after completion of stimulation
Crossover 1b: sham + anodal stimulation of M1	Active comparator	Device: Sham + Anodal stimulation of M16 amputees will undergo 8 sham treatments followed by 8 active treatments of 20 min 2mA anodal stimulation of M1 localized to the contralateral amputation area. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: * EEG and pain measurements * 20 minutes of stimulation * EEG and pain measurements after completion of stimulation
Crossover 2a: cathodal stimulation of M1 + sham	Active comparator	Device: Cathodal stimulation of M1 + sham6 amputees will undergo 8 active treatments of 20 min 2mA cathodal stimulation of M1 localized to the contralateral amputation area followed by 8 sham treatments. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: * EEG and pain measurements * 20 minutes of stimulation * EEG and pain measurements after completion of stimulation
Crossover 2b: sham + cathodal stimulation of M1	Active comparator	Device: Sham + Cathodal stimulation of M16 amputees will undergo 8 sham treatments followed by 8 active treatments of 20 min 2mA cathodal stimulation of M1 localized to the contralateral amputation area. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: * EEG and pain measurements * 20 minutes of stimulation * EEG and pain measurements after completion of stimulation

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 to 80
Limb amputation from at least 6 months before study enrollment
Presence of PLP at least 2 times a week and present 4 weeks prior to onset of study
Written informed consent

Key exclusion criteria (6 listed)

Coexistence of major neurological or psychiatric diseases
Being actively enrolled in a separate study targeting pain relief
Post traumatic stress disorder (PTSD) diagnosed patients
Any contraindication to noninvasive brain stimulation such as past brain surgery, brain implants, cochlear implant, epilepsy or any past seizure
Pregnant women

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
Anodal stimulation of M1 + shamAlso: tDCS8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.	Device	Crossover 1a: anodal stimulation of M1 + sham
Sham + Anodal stimulation of M1Also: tDCS8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).	Device	Crossover 1b: sham + anodal stimulation of M1
Cathodal stimulation of M1 + shamAlso: tDCS8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.	Device	Crossover 2a: cathodal stimulation of M1 + sham
Sham + Cathodal stimulation of M1Also: tDCS8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area).	Device	Crossover 2b: sham + cathodal stimulation of M1

Primary outcome

Reduced phantom limb pain
Time frame: 5 months after last stimulation session
Reduction of phantom limb pain compared to phantom limb pain before treatment, according to Visual Analog Scales (VAS) evaluation

2 secondary outcomes

Adverse effects of treatment
Time frame: Up to 5 weeks
Effects of treatment on the electrical activity of the brain
Time frame: Up to 5 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
Background: PubMed 12849487Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
Background: PubMed 2004259Cohen LG, Bandinelli S, Findley TW, Hallett M. Motor reorganization after upper limb amputation in man. A study with focal magnetic stimulation. Brain. 1991 Feb;114 ( Pt 1B):615-27. doi: 10.1093/brain/114.1.615.
Background: PubMed 11673327Lotze M, Flor H, Grodd W, Larbig W, Birbaumer N. Phantom movements and pain. An fMRI study in upper limb amputees. Brain. 2001 Nov;124(Pt 11):2268-77. doi: 10.1093/brain/124.11.2268.
Background: PubMed 17452283Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
Background: PubMed 14580622Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
Background: PubMed 16214292Nuti C, Peyron R, Garcia-Larrea L, Brunon J, Laurent B, Sindou M, Mertens P. Motor cortex stimulation for refractory neuropathic pain: four year outcome and predictors of efficacy. Pain. 2005 Nov;118(1-2):43-52. doi: 10.1016/j.pain.2005.07.020. Epub 2005 Oct 7.
Background: PubMed 16087918Khedr EM, Ahmed MA, Fathy N, Rothwell JC. Therapeutic trial of repetitive transcranial magnetic stimulation after acute ischemic stroke. Neurology. 2005 Aug 9;65(3):466-8. doi: 10.1212/01.wnl.0000173067.84247.36.
Background: PubMed 23707312Bolognini N, Olgiati E, Maravita A, Ferraro F, Fregni F. Motor and parietal cortex stimulation for phantom limb pain and sensations. Pain. 2013 Aug;154(8):1274-80. doi: 10.1016/j.pain.2013.03.040. Epub 2013 Apr 19.
Background: PubMed 10990547Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
Background: PubMed 23082174O'Connell NE, Cossar J, Marston L, Wand BM, Bunce D, Moseley GL, De Souza LH. Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA. PLoS One. 2012;7(10):e47514. doi: 10.1371/journal.pone.0047514. Epub 2012 Oct 17.
Background: PubMed 14677403Nitsche MA, Liebetanz D, Antal A, Lang N, Tergau F, Paulus W. Modulation of cortical excitability by weak direct current stimulation--technical, safety and functional aspects. Suppl Clin Neurophysiol. 2003;56:255-76. doi: 10.1016/s1567-424x(09)70230-2. No abstract available.
Background: PubMed 16427357Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.

Related trials for Phantom Limb Pain

RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
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Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
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Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee

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.

Itzhak Siev-Ner, MD principal investigator

Sheba Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Phantom Limb Pain, run by Sheba Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 27 Jan 2016. 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 Israel. 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.

Are results available for this study?

Results are not available in the source record.

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.

What does the primary outcome measure?

Reduced phantom limb pain (time frame: 5 months after last stimulation session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02051959, which also lists 28 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 27 Jan 2016.