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

The Centre for Advanced Research & Development, India

Status and phase

Unknown

Phase 2

Conditions

Multiple Sclerosis

Treatments

Device: Cytotron

Study type

Interventional

Funder types

Other

Identifiers

NCT01220830

100915_CIP_MS_V1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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