Assessing Possible Additive Effects of tDCS and Mirror Therapy Treatments for Phantom Pain
Does Transcranial Direct Current Stimulation (tDCS) Improve the Effect of Mirror Therapy? A Double-blind Randomized Controlled Study in Patients With Phantom Limb Pain.
1 other identifier
interventional
60
1 country
1
Brief Summary
In this study we will examine assess if treatment with transcranial Direct Current Stimulation (tDCS) improve the analgesic effects of mirror therapy for patients with phantom pain of lower extremity. The study will include 3 arms: only mirror therapy, mirror therapy + sham tDCS, and mirror therapy + active tDCS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2018
CompletedFirst Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedAugust 29, 2019
August 1, 2019
1.6 years
August 26, 2019
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) of the average Phantom Limb Pain in the past week will serve as primary measure. The primary outcome is the changes in the VAS score between baseline week and 4 weeks after the end of the treatment. VAS is a widely used, continuous measure of pain intensity, with scores ranging between 0-10, higher scores reflecting higher pain intensity.
between baseline week and 4 weeks after the end of the treatment
Secondary Outcomes (9)
McGill total score
between baseline week and 4 weeks after the end of the treatment
McGill sensory sub-score
between baseline week and 4 weeks after the end of the treatment
Changes in the worst pain
between baseline week and 4 weeks after the end of the treatment
Changes in the average pain
between baseline week and 4 weeks after the end of the treatment
Changes in the VAS score
between baseline week and 12 weeks after the end of the treatment
- +4 more secondary outcomes
Study Arms (3)
Mirror therapy
ACTIVE COMPARATORSubjects will be asked to perform specific movements (using the unaffected limb while watching its mirrored reflection for 20 minutes per day, for 10 treatment days, completed during two weeks (every weekday, excluding weekends)
Mirror therapy + sham tDCS
SHAM COMPARATORSubject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, a sham tDCS treatment will be applied.
Mirror therapy + active tDCS
EXPERIMENTALSubject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, an active tDCS treatment will be applied.
Interventions
tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
Eligibility Criteria
You may qualify if:
- Age 18 or older
- Underwent unilateral lower limb amputation in the past 3 months. A
- Reported average phantom pain of 4 or more in the past week.
- No change in other medications 1 week prior to enrollment, not including SOS.
- Able understand the purpose of the study and to provide informed consent.
You may not qualify if:
- \. Ferromagnetic metal in the head or neck.
- Epilepsy or prior seizures within the last 1 year.
- Suffering from severe depression
- History of unexplained fainting or loss of consciousness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loewenstein Hospital
Raanana, 43100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nitza Segal, M.A
Leowenstein Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Diractor
Study Record Dates
First Submitted
August 26, 2019
First Posted
August 28, 2019
Study Start
April 22, 2018
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
August 29, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share