Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Curr… (NCT02487966) | Clinical Trial CompassActive — Not RecruitingNot Applicable
Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
United States, Brazil132 participantsStarted 2015-07 Plain-language summary
This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham tDCS and sham MT (covered mirror).
Who can participate
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Inclusion criteria
- ✓. Able to provide informed consent to participate in the study.
- ✓. Subject is older than 18 years.
- ✓. Unilateral lower limb amputation.
- ✓. Traumatic amputation greater than 1 year ago.
- ✓. Chronic PLP for at least 3 months previous to enrollment in the study, experienced regularly for at least once a week.
- ✓. 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 and transcranial magnetic stimulation
- ✕. History of chronic pain previous to the amputation.
- ✕. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
- ✕
What they're measuring
1Changes in the Visual Analog Scale for Phantom Limb Pain
Timeframe: 4 weeks
Trial details
NCT IDNCT02487966
SponsorSpaulding Rehabilitation Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2020-03-27
Results submitted2021-04-30
. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
✕. Uncontrolled Epilepsy or prior seizures within the last 1 year.✕. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).\*