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

Mass General Brigham

Status: Completed

Conditions: Phantom Limb Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02627495

2015P002525

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

tDCS intervention (open label)

Experimental group

Description:

Subjects will undergo tDCS stimulation

Treatment:

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