NCT07139483 Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS
| NCT ID | NCT07139483 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Haifa |
| Condition | Phantom Limb Pain After Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2025-03-25 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Most amputees experience phantom limb pain (PLP), for years after amputation. Virtually all PLP research to date has focused on the mechanisms of chronic PLP, ignoring the mechanisms of chronification. This research project will focus on combined neuromodulatory interventions of mirror therapy (MT) and trans direct-cranial stimulation (tDCS), applied for the first time at the acute state of PLP, with an aim to prevent its chronification and chronicity. In PLP, maladaptive plasticity associated with sensory deafferentation following an amputation is one of the contributors for excessive pain. MT is a well-accepted yet limited option, which is thought to counterbalance abnormal plasticity. tDCS is an emerging approach believed to affect the membrane potential and activity threshold of cortical neurons. tDCS analgesic effectiveness, however, is mild and short, rendering it a noneffective stand-alone treatment. The researchers' objectives are to investigate whether the combined therapy of MT and tDCS will prevent chronic PLP and improve its related clinical characteristics. In addition, the researchers will investigate the behavioral manifestations effects of the combined treatment. The investigators expect that the combined treatment applied at the acute stage of PLP will have synergistic effects on PLP intensity and thus avert its chronification. In addition, it will reduce phantom sensations, and negative affect, and will improve the sense of body ownership and agency and endogenous inhibition efficiency. Research design: This randomized-controlled double-blinded study will be held at Israel's 3 largest rehabilitation centers. The study consists of 3 randomized patient arms (36 in each): (1) no-intervention, natural-course group; (2) MT + sham tDCS; (3) MT + real tDCS. MT and tDCS neuromodulatory interferences will be self-administered and consist of 20 sessions, completed during 4 weeks. The researchers outcome measures include: primary outcome: pain intensity, network-related behavioral markers, and amputation-related clinical characteristics. The data gathered will be collected at 5 timepoints. Research novelty and innovation: The researchers proposed model will provide insights on the prevention of PLP and, potentially, other neurological pathologies involving the dysfunction of sensory systems and integration and body perception.
Eligibility 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.
Contact & Investigator
Roi Treister, PhD
STUDY DIRECTOR
University of Haifa Faculty of Social Welfare and Health Sciences
Frequently Asked Questions
Who can join the NCT07139483 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Phantom Limb Pain After Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07139483 currently recruiting?
Yes, NCT07139483 is actively recruiting participants. Contact the research team at rtreister@univ.haifa.ac.il for enrollment information.
Where is the NCT07139483 trial being conducted?
This trial is being conducted at Raanana, Israel, Tel Aviv, Israel, Tel Aviv, Israel.
Who is sponsoring the NCT07139483 clinical trial?
NCT07139483 is sponsored by University of Haifa. The principal investigator is Roi Treister, PhD at University of Haifa Faculty of Social Welfare and Health Sciences. The trial plans to enroll 108 participants.