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

NCT02051959 | Suspended

• 1 other identifier: SHEBA-13-0733-IS-CTIL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain

Keywords

Phantom Limb Pain; Transcranial Direct Current Stimulation; Amputation; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse effects of treatment

  Up to 5 weeks

• Effects of treatment on the electrical activity of the brain

  Up to 5 weeks

Study Arms (4)

Crossover 1a: anodal stimulation of M1 + sham

ACTIVE COMPARATOR

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

Crossover 1b: sham + anodal stimulation of M1

ACTIVE COMPARATOR

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

Crossover 2a: cathodal stimulation of M1 + sham

ACTIVE COMPARATOR

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

Crossover 2b: sham + cathodal stimulation of M1

ACTIVE COMPARATOR

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

Interventions

Anodal stimulation of M1 + sham DEVICE

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

Also known as: tDCS

Crossover 1a: anodal stimulation of M1 + sham

Sham + Anodal stimulation of M1 DEVICE

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

Also known as: tDCS

Crossover 1b: sham + anodal stimulation of M1

Cathodal stimulation of M1 + sham DEVICE

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

Also known as: tDCS

Crossover 2a: cathodal stimulation of M1 + sham

Sham + Cathodal stimulation of M1 DEVICE

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

Also known as: tDCS

Crossover 2b: sham + cathodal stimulation of M1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Department of Orthopedic Rehabilitation, Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (28)

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• Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.

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MeSH Terms

Conditions

Phantom Limb; Diabetes Mellitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Itzhak Siev-Ner, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of The Department of Orthopedic Rehabilitation

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 31, 2014
• Study Start: May 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

IL (1)