Cytotron® Delivered Rotational Field Quantum Nuclear Magnetic Resonance Therapy for Multiple Sclerosis (RFQMR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by The Centre for Advanced Research & Development, India.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
The Centre for Advanced Research & Development, India
ClinicalTrials.gov Identifier:
NCT01220830
First received: October 9, 2010
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Device: Cytotron
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR) Based Tissue Engineering in the Treatment of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by The Centre for Advanced Research & Development, India:

Primary Outcome Measures:
  • Effect of RFQMR therapy on MS lesion confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Change from baseline to 90 days post therapy ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Effect of RFQMR therapy on disability status and quality of life of MS patients. [ Time Frame: Change from baseline to 90 days post therapy ] [ Designated as safety issue: No ]
    1. Change in Extended Disability Status Score (EDSS) from baseline to 90 days post therapy.
    2. Change in Functional Assessment for Multiple sclerosis (FAMS) score from baseline to 90 days post therapy.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RFQMR on Multiple Sclerosis lesions Device: Cytotron
Exposure to RFQMR with Cytotron for 28 consecutive days for one hour daily.
Other Name: CYTOTRON-RTE-6040-844GEN

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220830

Locations
India
Centre for Advanced Research and Development
Bangalore, Karnataka, India, 560 049
Sponsors and Collaborators
The Centre for Advanced Research & Development, India
Investigators
Principal Investigator: Ranjit Kumar, MD SCALENE CYBERNETICS LIMITED
  More Information

Publications:
Responsible Party: The Centre for Advanced Research & Development, India
ClinicalTrials.gov Identifier: NCT01220830     History of Changes
Other Study ID Numbers: 100915_CIP_MS_V1.0
Study First Received: October 9, 2010
Last Updated: September 16, 2011
Health Authority: India: Institutional Review Board

Keywords provided by The Centre for Advanced Research & Development, India:
Multiple sclerosis
RFQMR
Cytotron
EDSS
QOL assessment with FAMS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014