Clinical trial NCT02051959: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Phantom Limb Pain
Keywords: Phantom Limb Pain
Transcranial Direct Current Stimulation
Amputation
Diabetes Mellitus
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-01-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduced phantom limb pain
timeFrame: 5 months after last stimulation session
Secondary outcomes:
measure: Adverse effects of treatment
timeFrame: Up to 5 weeks
measure: Effects of treatment on the electrical activity of the brain
timeFrame: Up to 5 weeks
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Department of Orthopedic Rehabilitation, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Itzhak Siev-Ner, MD
role: PRINCIPAL_INVESTIGATOR
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