Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02627495 |
Recruitment Status :
Completed
First Posted : December 11, 2015
Results First Posted : April 23, 2021
Last Update Posted : May 11, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Phantom Limb Pain | Device: transcranial Direct Current Stimulation (tDCS): (Soterix ©) |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 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 |
Actual Study Start Date : | December 1, 2015 |
Actual Primary Completion Date : | November 22, 2019 |
Actual Study Completion Date : | March 9, 2021 |
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. |
- 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) ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Able to provide informed consent to participate in the study.
- Subject is older than 18 years.
- 3 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627495
United States, Massachusetts | |
Spaulding Rehabilitation Hospital | |
Boston, Massachusetts, United States, 02129 |
Documents provided by Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital:
Responsible Party: | Felipe Fregni, MD, PhD, MPH, Principal Investigator, Spaulding Rehabilitation Hospital |
ClinicalTrials.gov Identifier: | NCT02627495 |
Other Study ID Numbers: |
2015P002525 |
First Posted: | December 11, 2015 Key Record Dates |
Results First Posted: | April 23, 2021 |
Last Update Posted: | May 11, 2021 |
Last Verified: | April 2021 |
maladaptive plasticity Limb amputation phantom limb pain tDCS non-invasive brain stimulation |
Phantom Limb Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain |