None listed
Conditions
Brief summary
This pilot study explores a novel non-invasive therapy (Quantum Salt-Enhanced phototherapy) to promote neurological recovery after spinal cord injury. The intervention uses pulsed infrared light modulated by crystallised salts to target neuroinflammation and scar modulation. Ten participants with incomplete SCI will receive 15 consecutive 30-minute treatments. The study aims to assess safety and preliminary efficacy through motor-sensory and function scores.
Interventions
Participants will receive 15 consecutive daily sessions (30–50 minutes each) of Quantum Salt-Enhanced (QSE) phototherapy using the NeuroQSE device. This is a non-invasive, device-based intervention involving low-frequency pulsed infrared (IR) light, modulated through a matrix of crystallised bioactive substances. The infrared emitter operates within the 2.0–6.2 Hz range, depending on the specific substance in use. All sessions will be delivered by trained clinical staff at the study site. Participants will complete both phases described below. a) Description of Phase 1 and Phase 2 Phase 1 (Days 1–7): This phase uses modulation by: Magnesium Chloride (MgCl2) at 2.0–2.8 Hz Black Trepang extract (sea cucumber powder) at 3.8–4.2 Hz Phase 2 (Days 8–15): This phase uses modulation by: Biocompatible crystalline F3879 powder (previously referred to as gel) at 5.8–6.2 Hz Zinc Chloride (ZnCl2) and/or Calcium Chloride (CaCl2) at 3.0–3.8 Hz Each session consists of 3–4 segments of 10–15 minutes each. The emitter automatically cycles between crystalline substances and their corresponding frequency ranges. b) Infrared Frequency Parameters The following frequencies are applied using two modulation modes: Sweep mode: gradual frequency shift within a defined range (e.g. 2.0–2.8 Hz) Scan mode: discrete steps between programmed values (e.g. 3.0 Hz, 3.4 Hz, 3.8 Hz) Substance Frequency (Hz) Mode Used MgCl2 2.0–2.8 Sweep Trepang powder 3.8–4.2 Sweep ZnCl2 / CaCl2 3.0–3.8 Scan or sweep F3879 powder 5.8–6.2 Sweep c) Quantity of Crystalline Modulator per Session Total crystalline material used per session: approx. 0.5–0.8 grams Materials are sealed in single-use ampoules inside the emitter and do not contact the skin. d) Composition of Crystalline Ampoules Phase 1 ampoule composition: MgCl2 (40–60%) Trepang powder (40–50%) Phase 2 ampoule composition: ZnCl2 and/or CaCl2 (30–40%) F3879 powder (60–70%) All ampoules are pre-filled under GMP-like conditions. e) Application and Administration The crystalline materials are not applied to the skin. Sealed ampoules are inserted into the device by trained operators before each session. All sessions are administered by registered nurses or qualified technicians. f) Monitoring Adherence to the Intervention Daily session attendance logs are maintained. The device automatically records session duration and frequency parameters. Investigators complete and sign daily logs. Participants may optionally record symptoms in diaries.
Sponsors
Study design
Eligibility
Inclusion criteria
Aged 18–60 years Diagnosed with incomplete spinal cord injury (AIS B/C) within the last 3 years Able to attend daily 30-minute sessions for 15 days Able to give informed consent
Exclusion criteria
Complete SCI (AIS A) Active skin infection or injury at the treatment site Implanted electronic devices (e.g., pacemaker) Epilepsy or photosensitive conditions Uncontrolled pain or spasticity Pregnant or breastfeeding Participation in another interventional trial within the past 3 months