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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Progressive Supranuclear Palsy Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

active Deep TMS

Intervention Type 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).

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.

Group Type SHAM_COMPARATOR

sham Deep TMS

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type DEVICE