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

Not Applicable

Suspended

• Conditions: Phantom Limb Pain

• 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

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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