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

NCT ID: NCT02627495

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2021-03-09

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tDCS intervention (open label)

Subjects will undergo tDCS stimulation

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to provide informed consent to participate in the study.

2. Subject is older than 18 years.

3. 3 months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed.

4. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).

5. If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.

Exclusion Criteria

1. Pregnancy or trying to become pregnant in the next 2 months.

2. History of alcohol or drug abuse within the past 6 months as self-reported.

3. 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)

4. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported

5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).

6. Uncontrolled Epilepsy

7. Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).*

8. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.

9. History of neurosurgery, as self-reported.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni, MD, PhD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015P002525

Identifier Type: -

Identifier Source: org_study_id