Preventing phantom limb pain from becoming chronic with mirror therapy and tDCS
Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With Transcranial Direct Current Stimulation
This trial will try combining mirror therapy with transcranial direct current stimulation (tDCS) in adults who recently had a limb amputated and are experiencing early phantom limb pain to see if it prevents the pain from becoming long-term.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Haifa Academic / other |
| Locations | 3 sites (Raanana, Israel and 2 other locations) |
| Trial ID | NCT07139483 on ClinicalTrials.gov |
What this trial studies
The investigators will enroll adults with a single limb amputation within the past 12 weeks who report acute phantom limb pain and apply a combined intervention of mirror therapy and tDCS early after pain onset. Participants will receive supervised sessions of mirror-based sensorimotor training alongside noninvasive low‑current brain stimulation aimed at modulating cortical excitability. The protocol targets the acute phase of PLP to try to prevent maladaptive neuroplastic changes that contribute to chronification. Standard inclusion/exclusion criteria limit enrollment to patients with healed stumps and without neurological, psychiatric, or device-related contraindications.
Who should consider this trial
Good fit: Adults (18+) with a single limb amputation within the last 12 weeks who report acute phantom limb pain of at least 3/10 (and at least two weeks since first report), can understand the protocol, and consent are the intended participants.
Not a fit: People with unhealed stump wounds, prior seizures or other neurological/psychiatric contraindications, implanted devices or metal in the head, pregnancy, inability to consent, or those with longstanding chronic PLP outside the acute window are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined approach could reduce the chance that early phantom limb pain becomes chronic and lower the need for long-term pain medications.
How similar studies have performed: Mirror therapy has shown benefit in some patients with chronic PLP and tDCS alone yields mild, short-lived analgesia, but applying the two together in the acute post-amputation phase is a novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (age ≥18); * Amputation of a single limb ≤12 weeks ago; during this period of time, 80% of amputees develop PLP. Both upper and lower limb amputees are included to increase feasibility; * Acute PLP stage (2 weeks since first report), with intensity ≥3 on a 0-10 VAS; * No change in medication in past week, excluding pro re nata analgesics; * Can understand the study's purpose and instructions; * Agrees to participate and to provide written informed consent. Exclusion Criteria: * Stump wound not healed; * Other psychological, psychiatric, or neurological conditions; * Contraindications for tDCS or magnetic resonance imaging (MRI) (MRI data will not be analyzed in the proposed PhD project), including previous seizure, loss of consciousness due to head injury, metal in the head, implanted devices, claustrophobia, a skin condition or an unhealed wound on the scalp, and possibility of being pregnant; * Inability to provide informed consent or understand or carry out the experiment.
Where this trial is running
Raanana, Israel and 2 other locations
- Loewenstein Hospital — Raanana, Israel, Israel (Recruiting)
- Reut Medical Center — Tel Aviv, Israel, Israel (Recruiting)
- Sheba Medical Center — Tel Aviv, Israel (Not_yet_recruiting)
Study contacts
- Study coordinator: Roi Treister, PhD
- Email: rtreister@univ.haifa.ac.il
- Phone: +972533839935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.