Actively Recruiting
Preventing Chronification of Phantom Limb Pain Through Mirror Therapy Combined With Transcranial Direct Current Stimulation
Led by University of Haifa · Updated on 2025-09-08
108
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
Sponsors
U
University of Haifa
Lead Sponsor
L
Loewenstein Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to prevent the long-term development of phantom limb pain (PLP) in adults who have recently undergone limb amputation. Most amputees experience PLP, which can be severe and last for years. The study focuses on how combined neuromodulatory treatments using mirror therapy (MT) and transcranial direct current stimulation (tDCS) applied during the early acute phase of PLP might prevent chronic pain and improve related symptoms like phantom sensations, negative feelings, and body awareness. Participants will be randomly assigned to one of three groups: no intervention (natural course), MT with sham tDCS, or MT with real tDCS. Both MT and tDCS are self-administered through 20 daily sessions (excluding weekends) over four weeks, lasting 20 minutes each. The first two sessions occur in a clinic to train participants and caregivers, after which treatments can be done at home or in the clinic. The tDCS device is specially designed for home use and supports double-blind administration. Throughout the study, participants will continue their usual rehabilitation care, including physical therapy and medication. Data on pain intensity and other clinical and behavioral measures will be collected at five time points, focusing on pain levels four weeks after completing the interventions. Researchers will also assess body ownership, anxiety, depression, pain qualities, frequency of pain episodes, and other sensations related to amputation. The study will run until March 2029 and involves careful monitoring to evaluate the effectiveness of these combined treatments in preventing chronic PLP.
CONDITIONS
Brief Title
Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Amputation of a single limb within the past 12 weeks
- Experiencing acute phantom limb pain with an intensity of 3 or higher on a 0-10 pain scale
- No medication changes in the past week, except occasional pain relievers
- Ability to understand the study purpose and instructions
- Willingness to provide written informed consent
You will not qualify if you...
- Unhealed stump wound
- Presence of psychological, psychiatric, or neurological conditions other than phantom limb pain
- Contraindications for tDCS or MRI, including history of seizures, head injury with loss of consciousness, metal implants in the head, implanted devices, claustrophobia, scalp skin conditions or wounds, or possible pregnancy
- Inability to provide informed consent or understand/carry out study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 weeks
Participants self-administer Mirror Therapy combined with either real or sham transcranial direct current stimulation (tDCS) daily for 20 minutes, five days a week, over 4 weeks. The first two sessions occur at the clinic with training, and subsequent sessions may be at home or in the clinic.
20 sessions over 4 weeks, once daily excluding weekends, with first 2 sessions at clinic and remaining at home or clinic
Duration - 4 weeks
Participants are followed for assessment of pain intensity, sense of ownership and agency over the phantom limb, anxiety and depression, and other symptoms 4 weeks after treatment ends.
1 follow-up visit 4 weeks after treatment completion
Trial Site Locations
Total: 3 locations
1
Loewenstein Hospital
Raanana, Israel, Israel, Ahuza 278
Actively Recruiting
2
Reut Medical Center
Tel Aviv, Israel, Israel
Actively Recruiting
3
Sheba Medical Center
Tel Aviv, Israel
Not Yet Recruiting
Research Team
R
Roi Treister, PhD
S
Shlomit Sorek, BPT MPT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here