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

Study Overview
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Brief Summary
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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.

Official Title
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Long-Term Treatment of Patients Experiencing Phantom Limb Pain With Transcranial Direct Current Stimulation (tDCS)

Conditions
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Phantom Limb Pain

Intervention / Treatment
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* Device: Anodal stimulation of M1 + sham
* Device: Sham + Anodal stimulation of M1
* Device: Cathodal stimulation of M1 + sham
* Device: Sham + Cathodal stimulation of M1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crossover 1a: anodal stimulation of M1 + sham<br>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 | Device: Anodal stimulation of M1 + sham<br>* 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.<br>* Other names: tDCS;|
| Active Comparator: Crossover 1b: sham + anodal stimulation of M1<br>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 | Device: Sham + Anodal stimulation of M1<br>* 8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).<br>* Other names: tDCS;|
| Active Comparator: Crossover 2a: cathodal stimulation of M1 + sham<br>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 | Device: Cathodal stimulation of M1 + sham<br>* 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.<br>* Other names: tDCS;|
| Active Comparator: Crossover 2b: sham + cathodal stimulation of M1<br>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 | Device: Sham + Cathodal stimulation of M1<br>* 8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area).<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Measurement of the electrical activity of the brain before, during and after each stimulation using an electroencephalography (EEG) device. | Up to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phantom Limb Pain, Transcranial Direct Current Stimulation, Amputation, Diabetes Mellitus