Multiple SclerosisPhase 2RFQMRNCT01220830
Cytotron® Delivered Rotational Field Quantum Nuclear Magnetic Resonance Therapy for Multiple Sclerosis
A Phase 2 study testing Cytotron in people with Multiple Sclerosis, run by The Centre for Advanced Research & Development, India at 1 site in India.
Trial summary
The purpose of the study is to evaluate the efficacy of RFQMR therapy in remyelination in cases of Multiple sclerosis. The evaluation will be done based on MRI findings, by clinical/ neurological examination and by assessment of quality of life before and after completion of therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cytotron
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients with clinically definite MS according to Polman
- Age 18 to 60 yrs.
- EDSS 0 to 7.
- Relapse-free > 30 days prior to inclusion.
- Stable immunomodulatory or immunosuppressive. therapy or treatment for > 3 months prior to inclusion.
- In case of treatment with antidepressants:
- stable therapy > 3 months prior to inclusion.
- Highly effective methods of birth control for females.
Who cannot join
- Pregnancy
- Cardiac pacemakers, biostimulators, neurostimulators, cochlear implants, hearing aids.
- MRI incompatible implants like intramedullary nails, intracranial aneurysm clips, intra-orbital metal fragments, stents, implanted medication pumps etc near target area.
- Critically ill patients needing life support system.
- Mentally challenged patients who cannot give informed consent.
- Severely ill patients who cannot lie in supine position for 1 hour.
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- H/o brain injury and/ or any malignant disorder
- Personal or family history of epilepsy / brain tumor.
- Relapse of MS < 30 days prior to inclusion
- Change of immunomodulatory therapy < 30 days prior to inclusion
- Bipolar disorder
- History of stroke or other brain lesions
Trial locations and contacts
1 site in 1 country.
India1 site
Centre for Advanced Research and Development
Bangalore, Karnataka, 560 049
About this study
Official title: Efficacy of Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR) Based Tissue Engineering in the Treatment of Multiple Sclerosis
The purpose of the study is to evaluate the efficacy of RFQMR therapy in remyelination in cases of Multiple sclerosis.
The evaluation will be done based on MRI findings, by clinical/ neurological examination and by assessment of quality of life before and after completion of therapy.
Read the detailed description
Transmembrane Potential (TMP) is one of the known cellular signalling pathways regulating synthesis of various proteins like those responsible for programmed cell death (e.g., p53 group) at the appropriate time in living cells. Many illnesses like cancer and degenerative diseases are linked to disturbances in transmembrane potential and protein transcription process.(Cone CD, 1970)
The protein responsible for production of myelin by the oligodendrocytes is Connexin 32. It has been established that in cases of Multiple Sclerosis (MS) this protein is not synthesized by the oligodendrocytes thus leading to non-repair of the demyelination process in the Central Nervous System (CNS) (Scherer SS et al., 1995; Sargiannidou I et al., 2009; Bondurand N et al., 2001). This causes the fibrotic damage and plaque formation and consequent signs and symptoms of MS. RFQMR therapy addresses this process of stimulation of Oligodendrocytes to synthesize Connexin 32 thus causing remyelination.
RFQMR therapy is delivered with CYTOTRON®. This device is a long body, wide bore machine with 864 guns, with near field antennae and parabolic reflector delivery system. The device is capable of producing a wide range of dosimetry, involving multiple modulations in both fixed and variable proton density dosimetry. Appropriately modulated multi-harmonic Radio Frequency (RF) signals in the lower end of the electromagnetic spectrum can be used in altering the cell signaling process using the TMP pathways, thus able to tackle systemic disorders. Generically known as Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR), it is a technology that is made to deliver highly complex quantum instantaneous Nuclear Magnetic Resonance beams in the RF bands and its harmonics ranging from 3KHz to 300 MHz with a near field delivery using specialized antenna in the presence of high instantaneous magnetic field.
- Conditions
- Multiple Sclerosis
- Being tested
- Cytotron
- Keywords
- Multiple sclerosis, RFQMR, Cytotron, EDSS, QOL assessment with FAMS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytotronDevice
Also called CYTOTRON-RTE-6040-844GEN
Exposure to RFQMR with Cytotron for 28 consecutive days for one hour daily.
| Study group | Role | What they receive |
|---|---|---|
| RFQMR on Multiple Sclerosis lesions | Experimental | Not described Receives: Device: Cytotron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of RFQMR therapy on MS lesion confirmed by Magnetic Resonance Imaging (MRI)
- Change in number of T1 gadolinium- enhancing lesions on MRI from baseline to 90 days post therapy.
- Change in number of lesions on FLAIR MRI images from baseline to 90 days post therapy.
- Change in volume of five larger lesions of brain and spine from baseline to 90 days post therapy
Measured: Change from baseline to 90 days post therapy
Secondary outcomes (1)
Effect of RFQMR therapy on disability status and quality of life of MS patients.
- Change in Extended Disability Status Score (EDSS) from baseline to 90 days post therapy.
- Change in Functional Assessment for Multiple sclerosis (FAMS) score from baseline to 90 days post therapy.
Measured: Change from baseline to 90 days post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Centre for Advanced Research & Development, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranjit Kumar, MD, Principal investigator, SCALENE CYBERNETICS LIMITED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220830
- Sponsor's protocol ID
- 100915_CIP_MS_V1.0
- Acronym
- RFQMR
- Status last verified
- Sep 2011
- First submitted
- 9 Oct 2010
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cone CD Jr. Variation of the transmembrane potential level as a basic mechanism of mitosis control. Oncology. 1970;24(6):438-70. doi: 10.1159/000224545. No abstract available.
PubMed 5495918
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR) Based Tissue Engineering in the Treatment of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01220830
- Acronym / sponsor ID
- RFQMR / 100915_CIP_MS_V1.0
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, RFQMR, Cytotron, EDSS, QOL assessment with FAMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Centre for Advanced Research & Development, IndiaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy of RFQMR therapy in remyelination in cases of Multiple sclerosis.
The evaluation will be done based on MRI findings, by clinical/ neurological examination and by assessment of quality of life before and after completion of therapy.
Detailed description
Transmembrane Potential (TMP) is one of the known cellular signalling pathways regulating synthesis of various proteins like those responsible for programmed cell death (e.g., p53 group) at the appropriate time in living cells. Many illnesses like cancer and degenerative diseases are linked to disturbances in transmembrane potential and protein transcription process.(Cone CD, 1970)
The protein responsible for production of myelin by the oligodendrocytes is Connexin 32. It has been established that in cases of Multiple Sclerosis (MS) this protein is not synthesized by the oligodendrocytes thus leading to non-repair of the demyelination process in the Central Nervous System (CNS) (Scherer SS et al., 1995; Sargiannidou I et al., 2009; Bondurand N et al., 2001). This causes the fibrotic damage and plaque formation and consequent signs and symptoms of MS. RFQMR therapy addresses this process of stimulation of Oligodendrocytes to synthesize Connexin 32 thus causing remyelination.
RFQMR therapy is delivered with CYTOTRON®. This device is a long body, wide bore machine with 864 guns, with near field antennae and parabolic reflector delivery system. The device is capable of producing a wide range of dosimetry, involving multiple modulations in both fixed and variable proton density dosimetry. Appropriately modulated multi-harmonic Radio Frequency (RF) signals in the lower end of the electromagnetic spectrum can be used in altering the cell signaling process using the TMP pathways, thus able to tackle systemic disorders. Generically known as Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR), it is a technology that is made to deliver highly complex quantum instantaneous Nuclear Magnetic Resonance beams in the RF bands and its harmonics ranging from 3KHz to 300 MHz with a near field delivery using specialized antenna in the presence of high instantaneous magnetic field.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFQMR on Multiple Sclerosis lesions | Experimental | Device: Cytotron |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female patients with clinically definite MS according to Polman
- Age 18 to 60 yrs.
- EDSS 0 to 7.
- Relapse-free > 30 days prior to inclusion.
- Stable immunomodulatory or immunosuppressive. therapy or treatment for > 3 months prior to inclusion.
Key exclusion criteria (12 listed)
- Pregnancy
- Cardiac pacemakers, biostimulators, neurostimulators, cochlear implants, hearing aids.
- MRI incompatible implants like intramedullary nails, intracranial aneurysm clips, intra-orbital metal fragments, stents, implanted medication pumps etc near target area.
- Critically ill patients needing life support system.
- Mentally challenged patients who cannot give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytotronAlso: CYTOTRON-RTE-6040-844GENExposure to RFQMR with Cytotron for 28 consecutive days for one hour daily. | Device | RFQMR on Multiple Sclerosis lesions |
Primary outcome
Effect of RFQMR therapy on MS lesion confirmed by Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to 90 days post therapy
1. Change in number of T1 gadolinium- enhancing lesions on MRI from baseline to 90 days post therapy. 2. Change in number of lesions on FLAIR MRI images from baseline to 90 days post therapy. 3. Change in volume of five larger lesions of brain and spine from baseline to 90 days post therapy
1 secondary outcome
Effect of RFQMR therapy on disability status and quality of life of MS patients.
Time frame: Change from baseline to 90 days post therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2011.
- Background: PubMed 5495918Cone CD Jr. Variation of the transmembrane potential level as a basic mechanism of mitosis control. Oncology. 1970;24(6):438-70. doi: 10.1159/000224545. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjit Kumar, MD principal investigator
SCALENE CYBERNETICS LIMITED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytotron in people with Multiple Sclerosis, run by The Centre for Advanced Research & Development, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of RFQMR therapy on MS lesion confirmed by Magnetic Resonance Imaging (MRI) (time frame: Change from baseline to 90 days post therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2011.