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

• ClinicalTrials.gov Identifier: NCT02627495
• Recruitment Status: Active, not recruiting
• First Posted: December 11, 2015
• Last Update Posted: April 24, 2020
• Sponsor: Spaulding Rehabilitation Hospital
• Information provided by (Responsible Party): Felipe Fregni, Spaulding Rehabilitation Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Phantom Limb Pain	Device: transcranial Direct Current Stimulation (tDCS): (Soterix ©)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
• Study Start Date: December 2015
• Actual Primary Completion Date: November 22, 2019
• Estimated Study Completion Date: March 9, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: tDCS intervention (open label); Subjects will undergo tDCS stimulation

Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Pain as measured by the Visual Analog Scale [ Time Frame: Change in outcome from baseline to 2-week follow-up (after the last day of stimulation) ]

Secondary Outcome Measures :

1. depression level as measured by the Beck depression inventory [ Time Frame: post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
2. stump pain as measured by the "Visual Analog Scale for stump pain" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
3. phantom limb sensations as measured by the "Visual Analog Scale for phantom limb sensation" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
4. phantom limb telescopy as measured by the "Visual Analog Scale for phantom limb telescopy" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
5. anxiety as measured by the "Beck Anxiety Inventory" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
6. safety as measured by "Stroop Test" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline) ]
7. Quality of Life as measured by the "Health Survey SF-36" [ Time Frame: baseline; 2-week follow-up up (after the last day of stimulation) ]
8. Subjective Treatment Effectiveness measure (by the subject) as measured by the "Global Impression of Change scale" [ Time Frame: post-treatment (~1-2 weeks after baseline) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States, 02129

Sponsors and Collaborators

Spaulding Rehabilitation Hospital

Investigators

• Principal Investigator: Felipe Fregni, MD, PhD, MPH; Spaulding Rehabilitation Hospital

More Information

• Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT02627495
• Other Study ID Numbers: 2015P002525
• First Posted: December 11, 2015
• Last Update Posted: April 24, 2020
• Last Verified: April 2020

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:

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

Additional relevant MeSH terms:

Phantom Limb; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Signs and Symptoms; Pain