Deep TMS for the Treatment of Patients With Parkinson’s Disease and Progressive Supranuclear Palsy

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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