Magnetic Mitohormesis (MM) Treatment in Stroke Rehabilitation. (QTX-001)

October 4, 2026 updated by: QuantumTX Pte Ltd

Although sarcopenia is commonly seen in stroke patients with a prevalence rate of 42%, relevant research studies are more in geriatric population rather than in stroke patients. Beside conventional functional physiotherapy, improving blood circulation, improving cellular oxygenation and reducing inflammation by MM therapy is supposed to improve muscle atrophy after stroke, thus enhancing the functional recovery.

The investigators are not investigating the direct effect of MM therapy on muscle mass in the current study, but are looking at the function outcomes and changes in quality of life of patients after MM therapy, which is more relevant to the clinical practice in stroke recovery.

Based on literature review and previous studies, stroke patients might benefit from MM therapy by enhancing the outcomes in functional mobility and measures of quality of life, so the purpose of this study is to investigate if MM treatment could boost the functional recovery and muscle strength on top of the effects from the conventional physiotherapy.

The findings of this study might improve the medical knowledge on how MM therapy could affect clinical function outcome in post-stroke rehabilitation and provide alternative method to enhance motor recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this clinical trial, participants will be exposed to MM fields for 10 minutes per week for a maximum of 12 weeks in addition to standard clinical follow-up.

The route of administration, dosage, and frequency are based on studies done in vitro and in vivo models in mice and in adults. At the Swiss Federal Institute of Technology (ETH) in Zurich, the inventors of the MM device were contracted by the Swiss Agency (Bundesamt für Gesundheit, BAG) to test for the safety of diverse PEMF-delivery devices. The MM device was shown to be non-cytotoxic and non-transforming and produces pulsed magnetic fields at flux densities up to 2 mT peak and consists of a privately designed control unit and coil system. For clinical purposes the MM device will be working at less than this value (1.5 mT). Previous data showed enhancement in muscle with only 10 minutes of non-invasive MM fields exposure per week in mice.

In previous human trials, on healthy individuals following ACL-reconstructive surgery, exposure to MM fields showed muscle metabolic improvement and reduced muscle breakdown (measured effects of MM on serum ceramides, lysophosphatidylcholine, TNNT1 and P3NP), myokine upregulation reflecting improved muscle regeneration (measured effects of MM on Follistatin, IGF1, FGF21, IL-6). This was in response to two 10 minutes MM exposures per week on the operated leg. These findings helped to set up the treatment regime for the MM device to impose myogenic effects, including exposure time per session, number of treatment sessions and duration of treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 159053
        • Stroke Support Station (S3) - Enabling Village
    • Singapore
      • Singapore, Singapore, Singapore, 648886
        • Stroke Support Station (S3) - Jurong Point

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult age 30 - 70 years
  2. Diagnosis of stroke(s), with most recent stroke at least 10 weeks prior to study participation
  3. Functional Ambulation Categories (FAC): 2 to 3
  4. Normal cognition with Montreal Cognitive Assessment (MOCA) score 21
  5. Intact language skills to comprehend and follow directions as per Investigator's assessment.
  6. Individuals must agree to comply with all study visits and procedures.
  7. Individuals must freely provide consent to study participation.

Exclusion Criteria:

  1. Contraindications to PEMF therapy, which include electronic implants (e.g., pacemaker, implantable cardioverter defibrillator, cochlear implants)
  2. History of neurological disorder (e.g Seizure, Myasthenia Gravis, Multiple Sclerosis and Myopathies) other than stroke
  3. Pregnant and lactating women
  4. Simultaneously receiving standard care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham group

control group receiving the placebo
Device: Sham Mode MM Device

Sham sessions help to maintain participant blinding while eliminating the therapeutic electromagnetic field exposure. The sham device mode reproduces the visual and auditory characteristics of active MM treatment, including display screens, indicator lights, operational sounds, and treatment duration timer. However, no therapeutic electromagnetic field is generated.

MM devices can be configured to deliver either active treatment or sham treatment through the use of an RFID card reader. RFID cards are pre-programmed and randomised to correspond to either an active or sham session. When the assigned RFID card is tapped on the device, the corresponding treatment protocol is automatically initiated. Therefore double-blinding of both participants and study team / operators / assessors is possible
Active Comparator: Treated Group

Intervention group receiving MM therapy
Device: Quantum Magnetic

The intervention will be held at the stipulated study sites. Participants in the intervention group will be exposed to active pulse electromagnetic field treatment by a tested device. The active pulse electromagnetic field device does not produce heat or cause any sensation to the tissue which allows the participants to be blinded to the treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety - Safety profile and Number of participants with treatment-related AEs and SAEs
Time Frame: 16 weeks

To assess safety of MM in subacute stroke patients with moderately affected mobility for functional mobility training, assessed through number of participants with treatment-related adverse events, and safety evaluation of the adverse event (AE) profiles.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mobility - 10-Metre Walk Test
Time Frame: From baseline to 16 weeks

Gait speed assessed by 10-Metre Walk Test, administered by physiotherapist.
From baseline to 16 weeks
Mobility - 5 Times Sit To Stand Test
Time Frame: From baseline to 16 weeks

Lower limb strength assessed through the 5TSTS administered by a physiotherapist.
From baseline to 16 weeks
Mobility - Timed Up and Go
Time Frame: From baseline to 16 weeks

Dynamic balance assessed through the TUG administered by a physiotherapist.
From baseline to 16 weeks
Quality of Life - EuroQoL-5D-5L
Time Frame: From baseline to 16 weeks

EQ-5D-5L is an established tool for assessing the general health status of individuals across a wide array of health conditions and treatments. It measures health outcomes in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level scale, from no problems (level 1) to extreme problems (level 5), facilitating a comprehensive evaluation of a patient's health-related quality of life. The total score is derived by converting the individual dimension scores into a single summary index value, reflecting the overall health status, with higher scores indicating better health outcomes.
From baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
QuantumTX Pte Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gobinathan Chandran, National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QuantumTX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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