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

NCT01220830 | Unknown Phase 2 DMC

• 1 other identifier: 100915_CIP_MS_V1.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; RFQMR; Cytotron; EDSS; QOL assessment with FAMS

Outcome Measures

Primary Outcomes (1)

• Effect of RFQMR therapy on MS lesion confirmed by Magnetic Resonance Imaging (MRI)

  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

  Change from baseline to 90 days post therapy

Secondary Outcomes (1)

• Effect of RFQMR therapy on disability status and quality of life of MS patients.

  Change from baseline to 90 days post therapy

Study Arms (1)

RFQMR on Multiple Sclerosis lesions

EXPERIMENTAL

Device: Cytotron

Interventions

Cytotron DEVICE

Exposure to RFQMR with Cytotron for 28 consecutive days for one hour daily.

Also known as: CYTOTRON-RTE-6040-844GEN

RFQMR on Multiple Sclerosis lesions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients with clinically definite MS according to Polman
• Age 18 to 60 yrs.
• EDSS 0 to 7.
• In case of treatment with antidepressants:
• Highly effective methods of birth control for females.

You may not qualify if:

• 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.
• Bipolar disorder
• History of stroke or other brain lesions

Sponsors & Collaborators

• The Centre for Advanced Research & Development, India: lead

Study Sites (1)

Centre for Advanced Research and Development

Bangalore, Karnataka, 560 049, India

Location

Related Publications (1)

• 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.

  PMID: 5495918 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ranjit Kumar, MD

  SCALENE CYBERNETICS LIMITED

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2010
• First Posted: October 14, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 19, 2011

Record last verified: 2011-09

Locations

IN (1)