Not provided
Not provided
Not provided
Not provided
Not provided
Signing a contract with the company owning the equipment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Crossover sham control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| 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:
|
|
| 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:
|
|
| Crossover 2b: sham + cathodal stimulation of M1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal stimulation of M1 + sham | Device | 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduced phantom limb pain | Reduction of phantom limb pain compared to phantom limb pain before treatment, according to Visual Analog Scales (VAS) evaluation | 5 months after last stimulation session |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of treatment | Severity of any adverse effects related to the transcranial direct current stimulation treatment will be checked after each stimulation session | Up to 5 weeks |
| Effects of treatment on the electrical activity of the brain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Itzhak Siev-Ner, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedic Rehabilitation, Sheba Medical Center | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12849487 | Background | 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. | |
| 2004259 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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:
|
|
|
| Sham + Anodal stimulation of M1 | Device | 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 + sham | Device | 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 M1 | Device | 8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area). |
|
|
Measurement of the electrical activity of the brain before, during and after each stimulation using an electroencephalography (EEG) device.
| Up to 5 weeks |
| 11673327 | Background | 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. |
| 17452283 | Background | 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. |
| 14580622 | Background | 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. |
| 16214292 | Background | 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. |
| 16087918 | Background | 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. |
| 23707312 | Background | 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. |
| 10990547 | Background | 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. |
| 23082174 | Background | 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. |
| 14677403 | Background | 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. |
| 16427357 | Background | 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. |
| 7884476 | Background | 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. |
| 9547251 | Background | 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. |
| 11331390 | Background | 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. |
| 7777055 | Background | Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0. |
| 10408544 | Background | Roricht S, Meyer BU, Niehaus L, Brandt SA. Long-term reorganization of motor cortex outputs after arm amputation. Neurology. 1999 Jul 13;53(1):106-11. doi: 10.1212/wnl.53.1.106. |
| 8199341 | Background | Yang TT, Gallen CC, Ramachandran VS, Cobb S, Schwartz BJ, Bloom FE. Noninvasive detection of cerebral plasticity in adult human somatosensory cortex. Neuroreport. 1994 Feb 24;5(6):701-4. doi: 10.1097/00001756-199402000-00010. |
| 2243618 | Background | Hall EJ, Flament D, Fraser C, Lemon RN. Non-invasive brain stimulation reveals reorganized cortical outputs in amputees. Neurosci Lett. 1990 Aug 24;116(3):379-86. doi: 10.1016/0304-3940(90)90105-i. |
| 11166112 | Background | Grusser SM, Winter C, Muhlnickel W, Denke C, Karl A, Villringer K, Flor H. The relationship of perceptual phenomena and cortical reorganization in upper extremity amputees. Neuroscience. 2001;102(2):263-72. doi: 10.1016/s0306-4522(00)00491-7. |
| 15897507 | Background | Khedr EM, Kotb H, Kamel NF, Ahmed MA, Sadek R, Rothwell JC. Longlasting antalgic effects of daily sessions of repetitive transcranial magnetic stimulation in central and peripheral neuropathic pain. J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):833-8. doi: 10.1136/jnnp.2004.055806. |
| 15026508 | Background | Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Zerah F, Bendib B, Cesaro P, Keravel Y, Nguyen JP. Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. J Neurol Neurosurg Psychiatry. 2004 Apr;75(4):612-6. doi: 10.1136/jnnp.2003.022236. |
| 12927615 | Background | Brown JA, Barbaro NM. Motor cortex stimulation for central and neuropathic pain: current status. Pain. 2003 Aug;104(3):431-435. doi: 10.1016/S0304-3959(03)00209-4. No abstract available. |
| 1371745 | Background | Fuhr P, Cohen LG, Dang N, Findley TW, Haghighi S, Oro J, Hallett M. Physiological analysis of motor reorganization following lower limb amputation. Electroencephalogr Clin Neurophysiol. 1992 Feb;85(1):53-60. doi: 10.1016/0168-5597(92)90102-h. |
| 9386015 | Background | Elbert T, Sterr A, Flor H, Rockstroh B, Knecht S, Pantev C, Wienbruch C, Taub E. Input-increase and input-decrease types of cortical reorganization after upper extremity amputation in humans. Exp Brain Res. 1997 Oct;117(1):161-4. doi: 10.1007/s002210050210. |
| 9204932 | Background | Birbaumer N, Lutzenberger W, Montoya P, Larbig W, Unertl K, Topfner S, Grodd W, Taub E, Flor H. Effects of regional anesthesia on phantom limb pain are mirrored in changes in cortical reorganization. J Neurosci. 1997 Jul 15;17(14):5503-8. doi: 10.1523/JNEUROSCI.17-14-05503.1997. |
| 1792954 | Background | Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991;52:137-9. doi: 10.1007/978-3-7091-9160-6_37. |
| 12888036 | Background | Topper R, Foltys H, Meister IG, Sparing R, Boroojerdi B. Repetitive transcranial magnetic stimulation of the parietal cortex transiently ameliorates phantom limb pain-like syndrome. Clin Neurophysiol. 2003 Aug;114(8):1521-30. doi: 10.1016/s1388-2457(03)00117-2. |
| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
Not provided
Not provided