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

January 26, 2016 updated by: Dr. Itzhak Siev-Ner, Sheba Medical Center

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

  • 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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Department of Orthopedic Rehabilitation, Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Crossover 1a: anodal stimulation of M1 + sham

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
8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.
Other Names:
  • tDCS
Active Comparator: Crossover 1b: sham + anodal stimulation of M1

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
8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).
Other Names:
  • tDCS
Active Comparator: Crossover 2a: cathodal stimulation of M1 + sham

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
8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.
Other Names:
  • tDCS
Active Comparator: Crossover 2b: sham + cathodal stimulation of M1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced phantom limb pain
Time Frame: 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
5 months after last stimulation session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects of treatment
Time Frame: Up to 5 weeks
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
Time Frame: Up to 5 weeks
Measurement of the electrical activity of the brain before, during and after each stimulation using an electroencephalography (EEG) device.
Up to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Itzhak Siev-Ner, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-13-0733-IS-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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