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

IRCCS San Raffaele Roma

Status: Completed

Conditions: Parkinson's Disease; Progressive Supranuclear Palsy

Treatments: Device: active Deep TMS; Device: sham Deep TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02734485

RP 16/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• outpatients with PSP according to NINDS-SPSP criteria

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

active Deep Tms

Active Comparator group

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.

Treatment:

Device: active Deep TMS

sham deep tms

Sham Comparator group

Description:

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.

Treatment:

Device: sham Deep TMS