tSMS clinical applications
Accumulating evidence is supporting the use of tSMS as a therapeutic option for the following clinical indications.
Amyotrophic lateral sclerosis (ALS)
Our tSMS products offer a possible non-invasive disease-modifying therapy for ALS. The scientific rationale is that pathological cortical hyperexcitability contributes to the neurodegeneration of motor neurons through glutamatergic excitotoxicity. tSMS reduces cortical excitability and thus may slow down the neurodegeneration process by acting on its cause.
Proof-of-concept of this disease-modifying effect was first provided in a pilot study suggesting that tSMS of the motor cortex for 9-18 months can modify the progression of the disease. The study was published here:
Di Lazzaro V, Musumeci G, Boscarino M, De Liso A, Motolese F, Di Pino G, Capone F, Ranieri F. Transcranial static magnetic field stimulation can modify disease progression in amyotrophic lateral sclerosis. Brain Stimul. 2021 Jan-Feb;14(1):51-54. (pdf)
A follow-up randomised controlled trial (NCT04393467) demonstrated that long-term, home-based, self-administered tSMS in ALS is safe and feasible. tSMS of the motor cortex did not modify disease progression during the 6 months of treatment. However, long-term follow-up revealed a substantial increase in tracheostomy free survival in patients treated with real stimulation. The results were published here:
Di Lazzaro V, Ranieri F, Doretti A, Boscarino M, Maderna L, Colombo E, Soranna D, Zambon A, Ticozzi N, Musumeci G, Capone F, Silani V. Transcranial static magnetic stimulation for amyotrophic lateral sclerosis: a bicentric, randomised, double-blind placebo-controlled phase 2 trial. Lancet Reg Health Eur. 2024 Jul 30;45:101019. (pdf)
The clinical value of these results were remarked in the following commentary:
Senerchia G, Dubbioso R. Non-invasive brain stimulation therapy in amyotrophic lateral sclerosis: are we ready for clinical use? Lancet Reg Health Eur. 2024 Sep 6;45:101055. (pdf)
For more information: als@neurek.com
Parkinson's disease
A randomized controlled trial (NCT02657681) was conducted to test the hypothesis that tSMS of the motor cortex may improve levodopa-induced dyskinesias in patients with Parkinson's disease. The results demonstrated that home-based, self-administered tSMS is safe and feasible. Nine sessions of tSMS over two weeks compared to sham provided subjective benefit for the treatment of levodopa-induced dyskinesias. Objective benefit was not achieved, which should be investigated with longer tSMS treatments. The results were published here:
Dileone M, Ammann C, Catanzaro V, Pagge C, Piredda R, Monje MHG, Navalpotro-Gomez I, Bergareche A, Rodríguez-Oroz MC, Vela-Desojo L, Alonso-Frech F, Catalán MJ, Molina JA, López-Ariztegu N, Oliviero A, Obeso JA, Foffani G. Home-based transcranial static magnetic field stimulation of the motor cortex for treating levodopa-induced dyskinesias in Parkinson's disease: A randomized controlled trial. Brain Stimul. 2022 May-Jun;15(3):857-860. (pdf)
For more information: pd@neurek.com
Essential tremor
A randomized double-blind pilot study (NCT03780426) was conducted to test the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex may improve tremor in patients with essential tremor. Half of the patients received one session of tSMS of the left hemisphere and the other half of the right hemisphere, with contralateral sham stimulation.
Status: completed.
For more information: et@neurek.com