Clinical trial NCT02734485: Deep TMS for the Treatment of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
Official title: The Use of Deep TMS for the Treatment and Rehabilitation of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Supranuclear Palsy
Parkinson's Disease
Keywords: Progressive supranuclear palsy
Deep transcranial magnetic stimulation
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Progressive supranuclear palsy (PSP) is a rare neuro-degenerative disease, counted among atypical parkinsonism (AP). Medical treatment and rehabilitation are extremely limited in AP, therefore it would be very useful to find new ways to improve motor and non motor symptoms in PSP. The Brainway Deep Transcranial magnetic stimulation (DTMS) is a new technology of TMS using a particular coil, i.e. H-coil, able to stimulate deeper regions of the brain. Only few studies in literature have evaluated the efficacy of DTMS in Parkinson's Disease and parkinsonism; in particular in PSP patients, a case report showed an improvement in language.

Detailed description: Materials and Methods: This study was a pilot, randomized, cross-over, double blind trial. It was designed to evaluate the efficacy of Deep TMS in terms of recovery of motor functions, freezing of gait, and cognitive decline in patients with PSP. Nineteen subject underwent 14 session of high frequency DTMS over a 4 weeks period. The target were the left Broca and dorsolateral prefrontal cortex.

Eligibility criteria: Inclusion Criteria:

* outpatients with PSP according to NINDS-SPSP criteria

Exclusion Criteria:

* contraindications for DTMS (history of seizures, pacemakers, or any other electric device)

Primary outcomes:
measure: Change in PSP rating scale total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
timeFrame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period).
Secondary outcomes:
measure: Change in MoCA total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
timeFrame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
measure: Change in PDQ 39 total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
timeFrame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
measure: Change in NMS total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
timeFrame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
measure: Change in Hamilton rating scale for depression total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
timeFrame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Irccs San Raffaele Pisana
Study officials:
affiliation: IRCCS SAN RAFFAELE PISANA
name: Fabrizio Stocchi, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boeve BF. Progressive supranuclear palsy. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S192-4. doi: 10.1016/S1353-8020(11)70060-8.
citation: Levkovitz Y, Roth Y, Harel EV, Braw Y, Sheer A, Zangen A. A randomized controlled feasibility and safety study of deep transcranial magnetic stimulation. Clin Neurophysiol. 2007 Dec;118(12):2730-44. doi: 10.1016/j.clinph.2007.09.061. Epub 2007 Oct 30.
citation: Trebbastoni A, Raccah R, de Lena C, Zangen A, Inghilleri M. Repetitive deep transcranial magnetic stimulation improves verbal fluency and written language in a patient with primary progressive aphasia-logopenic variant (LPPA). Brain Stimul. 2013 Jul;6(4):545-53. doi: 10.1016/j.brs.2012.09.014. Epub 2012 Oct 24.