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Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS

RecruitingNAAges 18 Years - anyAllUniversity of Haifa
NCT07139483 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 no

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📋 Eligibility rules (as published)
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.
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What it tests

  • Trans Direct-Cranial Stimulation (tDCS)
  • Mirror therapy
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Where

3 sites
Loewenstein Hospital
Raanana, Israel
Reut Medical Center
Tel Aviv, Israel
Sheba Medical Center
Tel Aviv, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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