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

June 23, 2023 updated by: IRCCS San Raffaele Roma

The Use of Deep TMS for the Treatment and Rehabilitation of Patients With Parkinson's Disease and Progressive Supranuclear Palsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00163
        • IRCCS San Raffaele Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • outpatients with PSP according to NINDS-SPSP criteria

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Principal Investigator: Fabrizio Stocchi, MD, PHD, IRCCS San Raffaele Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimated)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 16/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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