Magnetic brain stimulation for multiple sclerosis trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: 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. CONDITION: multiple sclerosis; ; multiple sclerosis Neurological ‐ Multiple sclerosis PRIMARY OUTCOME: safety and tolerability of TMS in people with multiple sclerosis .Low intensity TMS is associated with very few if any side effects. It is well tolerated however participants can report mild headache and a feeling of mild disorientation usually transient. In rare circumstances seizure activity can occur. This is mitigated by exclusion of those at risk of seizures, All side effects will be recorded in the study by a study specific questionnaire at the end of each session and before the start of the next session. At the end of the study the participants will be asked at their exit visit about any side effects and also whether they thought they were in the active or sham groups.[6 weeks post baseline visit] SECONDARY OUTCOME: Change in cognition as measured by MS reactor at 6 weeks compared to baseline.[6 weeks post baseline visit] Change in depression as measured by change in the HADS depression score at 6 weeks compared to baseline. ; [6 weeks post baseline visit] Change in MRI remyelination measures between baseline and week 6 weeks of study. ; [6 weeks after baseline visit] 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
Epistemonikos ID: 57736fa746cf4434ca55c181d52c21f20d74beda
First added on: Aug 24, 2024