Cytotron® Delivered Rotational Field Quantum Nuclear Magnetic Resonanc
Efficacy of Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR) Based Tissue Engineering in the Treatment of Multiple Sclerosis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Cytotron
What it measured
Main measures
Effect of RFQMR therapy on MS lesion confirmed by Magnetic Resonance Imaging (MRI)
Change from baseline to 90 days post therapy
MRI lesions
Other measures (1)
Effect of RFQMR therapy on disability status and quality of life of MS patients.
Change from baseline to 90 days post therapy
Disability progressionQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 60 · EDSS 0 to 7
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Sept 2010
Main results due
Dec 2011
Finished
Dec 2011