Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment cytotron
Phase phase 2
Sponsor The Centre for Advanced Research & Development, India
Start date September 2010
End date December 2011
Trial size 40 participants
Trial identifier NCT01220830, 100915_CIP_MS_V1.0

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cytotron CYTOTRON-RTE-6040-844GEN
Exposure to RFQMR with Cytotron for 28 consecutive days for one hour daily.

Primary Outcomes

Measure
Effect of RFQMR therapy on MS lesion confirmed by Magnetic Resonance Imaging (MRI)
time frame: Change from baseline to 90 days post therapy

Secondary Outcomes

Measure
Effect of RFQMR therapy on disability status and quality of life of MS patients.
time frame: Change from baseline to 90 days post therapy

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Efficacy of Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR) Based Tissue Engineering in the Treatment of Multiple Sclerosis
Principal investigator Ranjit Kumar, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by The Centre for Advanced Research & Development, India.