None listed
Conditions
Brief summary
Transcranial magnetic stimulation is a safe and well proven technique used to treat a number of psychiatric and neurological disorders. It has never been trialled in MS. We have demonstrated that TMS may have an effect on the ability of brain cells to replenish the myelin sheath (the insulation surrounding nerve cells) which may thus help multiple sclerosis lesions to heal. This data is from animals and cell culture and has not been shown in humans. This study is a safety/tolerability study of TMS in humans to determine whether wee can give TMS to people with MS with acceptable tolerability and safety. We will also collect preliminary data on the effects of TMS on people with MS and their MRI scans
Interventions
Low intensity 10Hz theta burst transcranial magnetic stimulation or sham stimulation over the frontal head region for 6 minutes at a time for 20 sessions (one per week day) over 4 weeks. The same site will be used for each stimulation/sham stimulation using biometric landmarks recorded for all participants at the first study visit.This will be administered by trained research staff (PhD student and medical student) under the supervision of a TMS expert and direct medical supervision whilst in t
Low intensity 10Hz theta burst transcranial magnetic stimulation or sham stimulation over the frontal head region for 6 minutes at a time for 20 sessions (one per week day) over 4 weeks. The same site will be used for each stimulation/sham stimulation using biometric landmarks recorded for all participants at the first study visit.This will be administered by trained research staff (PhD student and medical student) under the supervision of a TMS expert and direct medical supervision whilst in the clinic setting. Random administrations will be observed by the supervising neurologist and also the TMS expert(psychologist). A trained and registered medical practitioner will be on site. All stimulations will be undertaken in the clinical research facility at the Menzies Institute for medical research, medical sciences precinct University of Tasmania.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Definite MS aged 18-65. either secondary progressive or relapsing remitting MS. Able to have an MRI scan. EDSS < /= to 6. At least moderate cerebral MS plaque load as determined by trial neurologist. Able to give informed consent . Not pregnant. Not on anti epileptic and antipsychotic medications. No metallic devices or foreign bodies
Exclusion criteria
Other types of MS Pregnancy . Unable to have an MRI scan. unable to provide consent. On antiepileptic or antipsychotic medications. History of other concomitant neurological disorder that may complicate assessment e.g. Parkinson's Epilepsy Migraine or Stroke.
Outcome results
None listed