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

Sheba Medical Center

Status: Suspended

Conditions: Phantom Limb Pain

Treatments: Device: Sham + Cathodal stimulation of M1; Device: Sham + Anodal stimulation of M1; Device: Cathodal stimulation of M1 + sham; Device: Anodal stimulation of M1 + sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02051959

SHEBA-13-0733-IS-CTIL

Details and patient eligibility

About

• 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups

Crossover 1a: anodal stimulation of M1 + sham

Active Comparator group

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

Treatment:

Device: Anodal stimulation of M1 + sham

Crossover 1b: sham + anodal stimulation of M1

Active Comparator group

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

Treatment:

Device: Sham + Anodal stimulation of M1

Crossover 2a: cathodal stimulation of M1 + sham

Active Comparator group

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

Treatment:

Device: Cathodal stimulation of M1 + sham

Crossover 2b: sham + cathodal stimulation of M1

Active Comparator group

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

Treatment:

Device: Sham + Cathodal stimulation of M1