Cytotron® Delivered Rotational Field Quantum Nuclear Magnetic Resonance Therapy for Multiple Sclerosis (RFQMR)
Recruitment status was: Active, not recruiting
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 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|
- 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 ]
- 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
- 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 ]
- 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.
|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)|
|Experimental: RFQMR on Multiple Sclerosis lesions||
Exposure to RFQMR with Cytotron for 28 consecutive days for one hour daily.
Other Name: CYTOTRON-RTE-6040-844GEN
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220830
|Centre for Advanced Research and Development|
|Bangalore, Karnataka, India, 560 049|
|Principal Investigator:||Ranjit Kumar, MD||SCALENE CYBERNETICS LIMITED|