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

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

Sponsors

Lead Sponsor: Sheba Medical Center

Source 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.

Overall Status Suspended
Start Date May 2015
Completion Date December 2017
Primary Completion Date June 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduced phantom limb pain 5 months after last stimulation session
Secondary Outcome
Measure Time Frame
Adverse effects of treatment Up to 5 weeks
Effects of treatment on the electrical activity of the brain Up to 5 weeks
Enrollment 24
Condition
Intervention

Intervention Type: Device

Intervention Name: Anodal stimulation of M1 + sham

Description: 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.

Arm Group Label: Crossover 1a: anodal stimulation of M1 + sham

Other Name: tDCS

Intervention Type: Device

Intervention Name: Sham + Anodal stimulation of M1

Description: 8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).

Arm Group Label: Crossover 1b: sham + anodal stimulation of M1

Other Name: tDCS

Intervention Type: Device

Intervention Name: Cathodal stimulation of M1 + sham

Description: 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.

Arm Group Label: Crossover 2a: cathodal stimulation of M1 + sham

Other Name: tDCS

Intervention Type: Device

Intervention Name: Sham + Cathodal stimulation of M1

Description: 8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area).

Arm Group Label: Crossover 2b: sham + cathodal stimulation of M1

Other Name: tDCS

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Itzhak Siev-Ner, MD Principal Investigator Sheba Medical Center
Location
Facility: Department of Orthopedic Rehabilitation, Sheba Medical Center
Location Countries

Israel

Verification Date

January 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Sheba Medical Center

Investigator Full Name: Dr. Itzhak Siev-Ner

Investigator Title: Head of The Department of Orthopedic Rehabilitation

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Crossover 1a: anodal stimulation of M1 + sham

Type: Active Comparator

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

Label: Crossover 1b: sham + anodal stimulation of M1

Type: Active Comparator

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

Label: Crossover 2a: cathodal stimulation of M1 + sham

Type: Active Comparator

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

Label: Crossover 2b: sham + cathodal stimulation of M1

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov