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

NCT02734485 | Completed DMC

• 1 other identifier: RP 16/13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Supranuclear Palsy; Parkinson's Disease

Keywords

Progressive supranuclear palsy; Deep transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Change in PSP rating scale total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)

  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 Outcomes (4)

• Change in MoCA total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)

  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)

  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)

  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)

  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

Study Arms (2)

active Deep Tms

ACTIVE COMPARATOR

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

sham deep tms

SHAM COMPARATOR

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

Interventions

active Deep TMS DEVICE

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).

active Deep Tms

sham Deep TMS DEVICE

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.

sham deep tms

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatients with PSP according to NINDS-SPSP criteria

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

Irccs San Raffaele Pisana

Rome, 00163, Italy

Location

Related Publications (4)

• Boeve BF. Progressive supranuclear palsy. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S192-4. doi: 10.1016/S1353-8020(11)70060-8.

  PMID: 22166432 BACKGROUND

• 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.

  PMID: 17977787 BACKGROUND

• 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.

  PMID: 23122915 BACKGROUND

• Radicati FG, Vacca L, Casali M, Tremigliozzi I, Alborghetti M, Lombardi M, Rossini PM, Stocchi F. Deep transcranial magnetic stimulation in progressive supranuclear palsy: a randomized double-blind, cross-over study. Neurol Sci. 2025 Dec;46(12):6923-6931. doi: 10.1007/s10072-025-08549-1. Epub 2025 Nov 12.

  PMID: 41219570 DERIVED

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Parkinson Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Synucleinopathies

Study Officials

• Fabrizio Stocchi, MD, PHD

  IRCCS SAN RAFFAELE PISANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 12, 2016
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)