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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)
Must not have
Head injury resulting in loss of consciousness for at least 30 min or post-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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had a head injury that made me lose consciousness for over 30 minutes or caused amnesia for more than a day.
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I do not have any uncontrolled health issues like diabetes or heart problems.
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I have severe depression according to the Beck Depression Inventory.
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I have had brain surgery.
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I have not undergone Mirror Therapy in the last 3 months.
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I have not had seizures or uncontrolled epilepsy in the past year.
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I had chronic pain before my amputation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in the Visual Analog Scale for Phantom Limb Pain
Secondary study objectives
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
139 Previous Clinical Trials
10,969 Total Patients Enrolled
Massachusetts Eye and Ear InfirmaryOTHER
109 Previous Clinical Trials
12,551 Total Patients Enrolled
Felipe Fregni, MD, PhD, MPHPrincipal InvestigatorSpaulding Rehabilitation Hospital
13 Previous Clinical Trials
476 Total Patients Enrolled

Media Library

Mirror Therapy: active Clinical Trial Eligibility Overview. Trial Name: NCT02487966 — N/A
Phantom Limb Pain Research Study Groups: Sham tDCS and sham Mirrory Therapy, Active tDCS and Active Mirror Therapy, Active tDCS and sham Mirror Therapy, Sham tDCS and active Mirror Therapy
Phantom Limb Pain Clinical Trial 2023: Mirror Therapy: active Highlights & Side Effects. Trial Name: NCT02487966 — N/A
Mirror Therapy: active 2023 Treatment Timeline for Medical Study. Trial Name: NCT02487966 — N/A
~13 spots leftby Dec 2025
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