Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Change in PSP rating scale total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Secondary Outcome
Change in MoCA total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Condition
Progressive Supranuclear Palsy
Intervention
active Deep TMS
Study Arms / Comparison Groups
active Deep Tms
Description: Each DTMS session consisted in two consecutive stimulations: a first low-frequency (1 Hz) stimulation in the motor cortex (110% of the motor threshold, for 15 minutes)and a second high-frequency (10Hz) one in the prefrontal cortex (100% motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).The coil contains two symmetric devices, perfectly designed to rouse both hemispheres at the same time.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
October 2013
Completion Date
September 2014
Primary Completion Date
September 2014
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)
Gender
All
Ages
30 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Fabrizio Stocchi, MD, PHD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT02734485
Organization ID
Deep TMS PARK
Responsible Party
Principal Investigator
Study Sponsor
IRCCS San Raffaele
Study Sponsor
Fabrizio Stocchi, MD, PHD, Principal Investigator, IRCCS SAN RAFFAELE PISANA
Verification Date
April 2016