Completed

Boston-Harvard Burn Injury Model System: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury

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What is being tested

Transcranial direct current stimulation (tDCS)

+ Transcranial direct current stimulation (tDCS)

Device
Who is being recruted

Neurologic Manifestations+8

+ Pain

+ Signs and Symptoms

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorSpaulding Rehabilitation Hospital
Last updated: March 17, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation. If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

NCT01795079
Principal SponsorSpaulding Rehabilitation Hospital
Last updated: March 17, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

34 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsSkin DiseasesSkin ManifestationsPathological Conditions, Signs and SymptomsWounds and InjuriesSkin and Connective Tissue DiseasesBurnsPruritusChronic Pain

Criteria

4 inclusion criteria required to participate
Age 18 or older
Burn injury occurring at least 3 weeks prior to enrollment
Burn injury with pain and/or itch that is moderate to severe
Providing informed consent to participate in the study
8 exclusion criteria prevent from participating
Contraindications to tDCS including implanted metal plates in the head or implanted brain medical devices
Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment: carbamazepine, oxcarbazepine, phenytoin
History of other neurological conditions associated with structural anatomical changes (i.e. stroke, brain injury, Parkinson's)
Learning disorders that may prevent patient's ability to complete assessments
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Subjects will undergo 20 minutes active tDCS.

Group II

Sham
Subjects will undergo 20 minutes of sham stimulation.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Spaulding Rehabilitation Hospital

Boston, United StatesOpen Spaulding Rehabilitation Hospital in Google Maps
CompletedOne Study Center