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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Cytotron

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560 049
      • Centre for Advanced Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RFQMR on Multiple Sclerosis lesions	Device: Cytotron; Exposure to RFQMR with Cytotron for 28 consecutive days for one hour daily.; Other Names: CYTOTRON-RTE-6040-844GEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline to 90 days post therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to 90 days post therapy

Collaborators and Investigators

• Sponsor: The Centre for Advanced Research & Development, India
• Investigators: Principal Investigator: Ranjit Kumar, MD, SCALENE CYBERNETICS LIMITED

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: October 9, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): September 19, 2011
• Last Update Submitted That Met QC Criteria: September 16, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Multiple sclerosis; EDSS; RFQMR; Cytotron; QOL assessment with FAMS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 100915_CIP_MS_V1.0