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

Primary Purpose

Phantom Limb Pain

Status
Suspended
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Anodal stimulation of M1 + sham
Sham + Anodal stimulation of M1
Cathodal stimulation of M1 + sham
Sham + Cathodal stimulation of M1
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain focused on measuring Phantom Limb Pain, Transcranial Direct Current Stimulation, Amputation, Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Orthopedic Rehabilitation, Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Crossover 1a: anodal stimulation of M1 + sham

Crossover 1b: sham + anodal stimulation of M1

Crossover 2a: cathodal stimulation of M1 + sham

Crossover 2b: sham + cathodal stimulation of M1

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Reduced phantom limb pain
Reduction of phantom limb pain compared to phantom limb pain before treatment, according to Visual Analog Scales (VAS) evaluation

Secondary Outcome Measures

Adverse effects of treatment
Severity of any adverse effects related to the transcranial direct current stimulation treatment will be checked after each stimulation session
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.

Full Information

First Posted
January 28, 2014
Last Updated
January 26, 2016
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02051959
Brief Title
Long-term Effects of Transcranial Direct Current Stimulation (tDCS) on Patients With Phantom Limb Pain (PLP)
Official Title
Long-Term Treatment of Patients Experiencing Phantom Limb Pain With Transcranial Direct Current Stimulation (tDCS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Suspended
Why Stopped
Signing a contract with the company owning the equipment
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 stimulation method, in producing long-term reduction of phantom limb pain among amputees who experience such pain. This is a Crossover sham control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
Phantom Limb Pain, Transcranial Direct Current Stimulation, Amputation, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crossover 1a: anodal stimulation of M1 + sham
Arm Type
Active Comparator
Arm Description
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
Arm Title
Crossover 1b: sham + anodal stimulation of M1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Crossover 2a: cathodal stimulation of M1 + sham
Arm Type
Active Comparator
Arm Description
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
Arm Title
Crossover 2b: sham + cathodal stimulation of M1
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Anodal stimulation of M1 + sham
Other Intervention Name(s)
tDCS
Intervention Description
8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.
Intervention Type
Device
Intervention Name(s)
Sham + Anodal stimulation of M1
Other Intervention Name(s)
tDCS
Intervention Description
8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).
Intervention Type
Device
Intervention Name(s)
Cathodal stimulation of M1 + sham
Other Intervention Name(s)
tDCS
Intervention Description
8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.
Intervention Type
Device
Intervention Name(s)
Sham + Cathodal stimulation of M1
Other Intervention Name(s)
tDCS
Intervention Description
8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area).
Primary Outcome Measure Information:
Title
Reduced phantom limb pain
Description
Reduction of phantom limb pain compared to phantom limb pain before treatment, according to Visual Analog Scales (VAS) evaluation
Time Frame
5 months after last stimulation session
Secondary Outcome Measure Information:
Title
Adverse effects of treatment
Description
Severity of any adverse effects related to the transcranial direct current stimulation treatment will be checked after each stimulation session
Time Frame
Up to 5 weeks
Title
Effects of treatment on the electrical activity of the brain
Description
Measurement of the electrical activity of the brain before, during and after each stimulation using an electroencephalography (EEG) device.
Time Frame
Up to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itzhak Siev-Ner, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedic Rehabilitation, Sheba Medical Center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
12849487
Citation
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.
Results Reference
background
PubMed Identifier
2004259
Citation
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.
Results Reference
background
PubMed Identifier
11673327
Citation
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.
Results Reference
background
PubMed Identifier
17452283
Citation
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.
Results Reference
background
PubMed Identifier
14580622
Citation
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.
Results Reference
background
PubMed Identifier
16214292
Citation
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.
Results Reference
background
PubMed Identifier
16087918
Citation
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.
Results Reference
background
PubMed Identifier
23707312
Citation
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.
Results Reference
background
PubMed Identifier
10990547
Citation
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.
Results Reference
background
PubMed Identifier
23082174
Citation
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.
Results Reference
background
PubMed Identifier
14677403
Citation
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.
Results Reference
background
PubMed Identifier
16427357
Citation
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.
Results Reference
background
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
9547251
Citation
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.
Results Reference
background
PubMed Identifier
11331390
Citation
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.
Results Reference
background
PubMed Identifier
7777055
Citation
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.
Results Reference
background
PubMed Identifier
10408544
Citation
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.
Results Reference
background
PubMed Identifier
8199341
Citation
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.
Results Reference
background
PubMed Identifier
2243618
Citation
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.
Results Reference
background
PubMed Identifier
11166112
Citation
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.
Results Reference
background
PubMed Identifier
15897507
Citation
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.
Results Reference
background
PubMed Identifier
15026508
Citation
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.
Results Reference
background
PubMed Identifier
12927615
Citation
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.
Results Reference
background
PubMed Identifier
1371745
Citation
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.
Results Reference
background
PubMed Identifier
9386015
Citation
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.
Results Reference
background
PubMed Identifier
9204932
Citation
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.
Results Reference
background
PubMed Identifier
1792954
Citation
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.
Results Reference
background
PubMed Identifier
12888036
Citation
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.
Results Reference
background

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

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