Dual Stimulation for Spinal Cord Injury

NCT07467850 | Completed FDA Device

• 1 other identifier: 2022P001088
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

sci; trans-spinal electrical stimulation; photobiomodulation

Outcome Measures

Primary Outcomes (2)

• Device Feasibility (functionality of the prototype device)

  Device feasibility will be evaluated by device operability throughout the intervention period, these measurements will include; skin bioimpedance (Ohms), ramping up and down of electrical current in mA, and voltage stability during the stimulation (mA) period. Skin bioimpedance, ramping, and voltage stability will be combined to report device functionality represented as optimal stimulation or non-optimal.

  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.

• Intervention safety through adverse events analysis as measured by the Common Terminology Criteria for Adverse Events (CTCAE)

  Number of Participants presenting Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)

  Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.

Secondary Outcomes (11)

• The American Spinal Cord Injury Association test (ASIA)

  Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.

• Visual Analogue Scale (VAS)

  Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.

• Reflex recovery

  Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.

• Spinal Cord Injury - Functional Index (SCI-FI)

  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.

• The modified Ashworth scale (MAS)

  Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.

Study Arms (1)

Non-invasive dual electrical neuromodulation and photobiomodulation

EXPERIMENTAL

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

Device: tsDCS+pDCS; Device: Low-level laser therapy

Interventions

tsDCS+pDCS DEVICE

Pathmaker Neurosystems Inc. "MyoRegulator" trans-spinal and peripheral direct current stimulation.

Also known as: MyoRegulator, trans-spinal and peripheral direct current stimulation

Non-invasive dual electrical neuromodulation and photobiomodulation

Low-level laser therapy DEVICE

Erchonia Corp. "Erchonia FX405" low level laser

Also known as: photobiomodulation, LLLT, FX405, cold laser

Non-invasive dual electrical neuromodulation and photobiomodulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 or older with traumatic SCI (ASIA A-B).
• The injury has less than six months of evolution.
• Patients admitted to the Spaulding SCI Rehabilitation Unit at Spaulding Rehabilitation Hospital.
• Respiratory and hemodynamically stable.

You may not qualify if:

• They have any contraindications for receiving tsDCS, such as skin wounds in the place of application.
• Any known hypersensitivity to light therapy
• Any substantial decrease in alertness, language reception, or attention that might interfere with understanding
• Current use of a ventilator
• Compromised medical status due to uncontrolled pathologies such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardizes the patient's participation in the study
• Pregnancy or breastfeeding. People with childbearing capacity who are eligible to participate in the study will be tested for pregnancy by serum human chorionic gonadotropin (hCG) test.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• PathMaker Neurosystems Inc.: collaborator
• Erchonia Corporation: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

Related Publications (63)

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MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Director, Spaulding Neuromodulation Center

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: March 12, 2026
• Study Start: July 14, 2022
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)