Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000849493p
Ethics application status
Submitted, not yet approved
Date submitted
4/07/2025
Date registered
6/08/2025
Date last updated
6/08/2025
Date data sharing statement initially provided
6/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of Quantum Salt-Enhanced (QSE) Phototherapy for Spinal Cord Injury
Scientific title
A Pilot Clinical Study of Quantum Salt-Enhanced (QSE) Phototherapy for Enhancing Neurological Recovery in Individuals with Spinal Cord Injury
Secondary ID [1] 314813 0
None
Universal Trial Number (UTN)
Trial acronym
NeuroQSE-SCI
Linked study record



Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 338067 0
Condition category
Condition code
Neurological 334363 334363 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331411 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342050 0
Change in sensory-motor function
Timepoint [1] 342050 0
Baseline (Day 0, prior to intervention) and Day 15 post-intervention commencement.
Secondary outcome [1] 449426 0
Presence and extent of spinal cord scar tissue
Timepoint [1] 449426 0
Baseline (Day 0, prior to first intervention) and Day 15 post-intervention commencement

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to analyse pre- and post-treatment changes in motor/sensory scores, participant-reported measures, and safety data. Paired t-tests or non-parametric equivalents may be used for within-subject comparisons.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/08/2025
Actual
Date of last participant enrolment
Anticipated
25/10/2025
Actual
Date of last data collection
Anticipated
25/11/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 27182 0
New Zealand
State/province [1] 27182 0

Funding & Sponsors
Funding source category [1] 319373 0
Commercial sector/Industry
Name [1] 319373 0
Quantech Group Limited
Country [1] 319373 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Quantech Group Limited
Address
Country
New Zealand
Secondary sponsor category [1] 321858 0
None
Name [1] 321858 0
None
Address [1] 321858 0
Country [1] 321858 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317948 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 317948 0
Ethics committee country [1] 317948 0
New Zealand
Date submitted for ethics approval [1] 317948 0
10/07/2025
Approval date [1] 317948 0
Ethics approval number [1] 317948 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142650 0
Mr Viktor Volkov
Address 142650 0
Quantech Group Ltd – Clinical Research Division (Proposed study site, pending final site agreement) Health Space Clinic Unit 6, 44 Silverdale Street Silverdale, Auckland 0932 New Zealand
Country 142650 0
New Zealand
Phone 142650 0
+64 2108792360
Fax 142650 0
Email 142650 0
[email protected]
Contact person for public queries
Name 142651 0
Viktor Volkov
Address 142651 0
Quantech Group Ltd – Clinical Research Division (Proposed study site, pending final site agreement) Health Space Clinic Unit 6, 44 Silverdale Street Silverdale, Auckland 0932 New Zealand
Country 142651 0
New Zealand
Phone 142651 0
+64 2108792360
Fax 142651 0
Email 142651 0
[email protected]
Contact person for scientific queries
Name 142652 0
Viktor Volkov
Address 142652 0
Quantech Group Ltd – Clinical Research Division (Proposed study site, pending final site agreement) Health Space Clinic Unit 6, 44 Silverdale Street Silverdale, Auckland 0932 New Zealand
Country 142652 0
New Zealand
Phone 142652 0
+64 2108792360
Fax 142652 0
Email 142652 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Must comply with NZ data privacy and ethics standards



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] Available upon request after publication.


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.