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Deep TMS for the Treatment of Patients With Parkinson's Disease and Progressive Supranuclear Palsy (DeepTMSPARK)

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ClinicalTrials.gov Identifier: NCT02734485
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Fabrizio Stocchi, MD, PhD, IRCCS San Raffaele

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.

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Parkinson's Disease Device: active Deep TMS Device: sham Deep TMS Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: The Use of Deep TMS for the Treatment and Rehabilitation of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
Study Start Date : October 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014


Arm Intervention/treatment
Active Comparator: active Deep Tms
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.
Device: active Deep TMS

The Brainsway DTMS produces a time-varying magnetic field and, based on Faraday's Law, it can be assumed that a time-varying magnetic field generates an electrical current in a nearby conductive substance. The induced electric current in the cortex travels in an orthogonal path in the direction of the magnetic field with the maximum strength and current located beneath the coil in the helmet placed on the patient's head and transmits magnetic pulses to the patient's brain. The induced current is tangential to the scalp at the cortical surface, and decreases in magnitude with increasing depth.

Patients underwent 12 sessions, 3 times a week, of repetitive DTMS using the novel H2-coil (Brainsway LDT).


Sham Comparator: sham deep tms
The Sham DTMS consisted in the same protocol of active treatment with the same preparation of the subject and settings of the instrument but with an inactive DTMS coil.
Device: sham Deep TMS
The Sham DTMS consisted in the same protocol of active treatment with the same preparation of the subject and settings of the instrument but with an INACTIVE DTMS coil.




Primary Outcome Measures :
  1. Change in PSP rating scale total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3) [ Time Frame: 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). ]
    Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation: T1 for first period, T3 for second period).


Secondary Outcome Measures :
  1. Change in MoCA total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3) [ Time Frame: 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 ]
    Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation: T1 for first period, T3 for second period).

  2. Change in PDQ 39 total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3) [ Time Frame: 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 ]
    Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time

  3. Change in NMS total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3) [ Time Frame: 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 ]
    Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time

  4. Change in Hamilton rating scale for depression total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3) [ Time Frame: 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 ]
    Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734485


Locations
Italy
Irccs San Raffaele Pisana
Rome, Italy, 00163
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Fabrizio Stocchi, MD, PHD IRCCS SAN RAFFAELE PISANA

Publications:
Responsible Party: Fabrizio Stocchi, MD, PhD, Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT02734485     History of Changes
Other Study ID Numbers: Deep TMS PARK
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Fabrizio Stocchi, MD, PhD, IRCCS San Raffaele:
Progressive supranuclear palsy
Deep transcranial magnetic stimulation

Additional relevant MeSH terms:
Parkinson Disease
Paralysis
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Eye Diseases