Dual Stimulation for Spinal Cord Injury

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT07467850
Status
Completed

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tsDCS+pDCS — DEVICE
    Pathmaker Neurosystems Inc. "MyoRegulator" trans-spinal and peripheral direct current stimulation.
  • Low-level laser therapy — DEVICE
    Erchonia Corp. "Erchonia FX405" low level laser

Study Details

The goal of this Spinal Cord Injury (SCI) Open-Label Clinical Trial is to test the safety and feasibility of the intervention. The study aims to answer whether implementing this intervention on inpatients at a specialized rehabilitation hospital is possible. All participants will receive the intervention and be asked to report side effects and tolerability. Additionally, injury markers for safety and signal recordings to detect changes will be assessed pre- and post-intervention.

Key Dates

Start date
Jul 14, 2022
Status verified
Mar 2026
Primary completion
Jul 1, 2024
Completion
Sep 1, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Non-invasive dual electrical neuromodulation and photobiomodulation
    Trans-spinal direct current stimulation (tsDCS) + peripheral direct current stimulation (pDCS) Spinal maximum value 4 milliamps (mA) Peripheral maximum value 1 mA Duration per treatment 20 minutes per session Total of 10 sessions AND Low-level laser therapy (LLLT) with 635nm red diodes and 405nm violet diode

Primary Outcome Measure

Device Feasibility (functionality of the prototype device) [ Time Frame: Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Rehabilitation HospitalBostonMassachusetts02129-

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