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Mirror Therapy + tDCS for Phantom Limb Pain
N/A
Waitlist Available
Led By Felipe Fregni, MD, PhD, MPH
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unilateral lower limb amputation
Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial is testing the effectiveness of two different treatments, mirror therapy and transcranial Direct Current Stimulation, for stroke patients. The patients will be randomly assigned to one of four groups, two of which will receive active treatment and two of which will receive sham treatment.
Who is the study for?
This trial is for adults over 18 with unilateral lower limb amputation from trauma at least a year ago, suffering from chronic phantom limb pain (PLP) regularly and rating their pain at least 4 out of 10. Medications must be stable for two weeks before joining. Exclusions include pregnancy, unstable medical conditions, recent mirror therapy, drug/alcohol abuse, certain metal implants or electronic devices in the head/neck, severe depression, uncontrolled epilepsy/seizures.Check my eligibility
What is being tested?
The study tests mirror therapy combined with transcranial Direct Current Stimulation (tDCS) to treat PLP. Participants are randomly placed into one of four groups: both active tDCS and active mirror therapy; sham tDCS with active mirror therapy; active tDCS with sham mirror therapy; or both treatments as shams.See study design
What are the potential side effects?
Potential side effects may include discomfort at the electrode site during tDCS treatment and mild headaches or tingling sensations. Mirror Therapy generally does not have associated side effects but could potentially cause psychological discomfort if patients react negatively to the visual illusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had one of my legs amputated.
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My average pain level last week was 4 or higher on a scale of 0 to 10.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in the Visual Analog Scale for Phantom Limb Pain
Secondary outcome measures
Changes in the Visual Analog Scale for Phantom Limb Sensation
Changes in the Visual Analog Scale for Stump Pain
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Sham tDCS and active Mirror TherapyExperimental Treatment2 Interventions
Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.
Group II: Active tDCS and sham Mirror TherapyExperimental Treatment2 Interventions
Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.
Group III: Active tDCS and Active Mirror TherapyExperimental Treatment2 Interventions
Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.
Group IV: Sham tDCS and sham Mirrory TherapyPlacebo Group2 Interventions
Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.
Find a Location
Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
134 Previous Clinical Trials
10,883 Total Patients Enrolled
Massachusetts Eye and Ear InfirmaryOTHER
106 Previous Clinical Trials
12,817 Total Patients Enrolled
Felipe Fregni, MD, PhD, MPHPrincipal InvestigatorSpaulding Rehabilitation Hospital
13 Previous Clinical Trials
476 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have fainted or lost consciousness for no clear reason in the past 2 years.You have had problems with alcohol or drug abuse in the last 6 months.My medication doses have been the same for at least 2 weeks.I have had one of my legs amputated.I had a limb amputated over a year ago.My average pain level last week was 4 or higher on a scale of 0 to 10.I've had a head injury that made me lose consciousness for over 30 minutes or caused amnesia for more than a day.I do not have any uncontrolled health issues like diabetes or heart problems.I have severe depression according to the Beck Depression Inventory.I have had brain surgery.I have not undergone Mirror Therapy in the last 3 months.I am older than 18 years.I have not had seizures or uncontrolled epilepsy in the past year.I have had chronic pain for at least 3 months, feeling it weekly.I had chronic pain before my amputation.You have metal objects in your head or electronic medical devices in your head or neck.
Research Study Groups:
This trial has the following groups:- Group 1: Sham tDCS and sham Mirrory Therapy
- Group 2: Active tDCS and Active Mirror Therapy
- Group 3: Active tDCS and sham Mirror Therapy
- Group 4: Sham tDCS and active Mirror Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities currently available for participants in this research?
"This research endeavour is no longer searching for clinical trial participants; the listing was initially uploaded on July 1st, 2015 and has been amended as recently as August 11th, 2022. Fortunately, there are 44 other studies actively welcoming enrolment currently."
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