Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees

NCT02627495 | Completed Results

• 1 other identifier: 2015P002525
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.

Conditions

Phantom Limb Pain

Keywords

maladaptive plasticity; Limb amputation; phantom limb pain; tDCS; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• Pain as Measured by the Visual Analog Scale

  The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain.

  Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)

Study Arms (1)

tDCS intervention (open label)

EXPERIMENTAL

Subjects will undergo tDCS stimulation

Device: transcranial Direct Current Stimulation (tDCS): (Soterix ©)

Interventions

transcranial Direct Current Stimulation (tDCS): (Soterix ©) DEVICE

Subjects will undergo tDCS stimulation. We will use electrodes of 35cm\^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.

tDCS intervention (open label)

Eligibility Criteria

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

You may qualify if:

• Able to provide informed consent to participate in the study.
• Subject is older than 18 years.
• months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed.
• Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
• If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.

You may not qualify if:

• Pregnancy or trying to become pregnant in the next 2 months.
• History of alcohol or drug abuse within the past 6 months as self-reported.
• Presence of the following contraindication to transcranial direct current stimulation Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) Implanted head electronic medical devices (e.g., cochlear implants)
• Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
• Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
• Uncontrolled Epilepsy
• Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).\*
• History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
• History of neurosurgery, as self-reported.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Phantom Limb

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Prof. Felipe Fregni
• Organization: Spaulding Rehabilitation Hospital

Fregni.Felipe@mgh.harvard.edu

+1 (617) 935-2743

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: November 22, 2019
• Study Completion: March 9, 2021
• Last Updated: May 11, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-04

Locations

US (1)