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

Not Applicable

Suspended

• Conditions: Phantom Limb Pain
• Interventions: Device: Sham + Cathodal stimulation of M1; Device: Anodal stimulation of M1 + sham; Device: Sham + Anodal stimulation of M1; Device: Cathodal stimulation of M1 + sham

• Registration Number: NCT02051959
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Study Start: 2015-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crossover 2b: sham + cathodal stimulation of M1	Sham + Cathodal stimulation of M1	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
Crossover 1a: anodal stimulation of M1 + sham	Anodal stimulation of M1 + sham	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
Crossover 1b: sham + anodal stimulation of M1	Sham + Anodal stimulation of M1	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
Crossover 2a: cathodal stimulation of M1 + sham	Cathodal stimulation of M1 + sham	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

Primary Outcome Measures

Name	Time	Method
Reduced phantom limb pain	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

Secondary Outcome Measures

Name	Time	Method
Adverse effects of treatment	Up to 5 weeks	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	Up to 5 weeks	Measurement of the electrical activity of the brain before, during and after each stimulation using an electroencephalography (EEG) device.

Trial Locations

Locations (1)

Department of Orthopedic Rehabilitation, Sheba Medical Center; 🇮🇱 Ramat Gan, Israel