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

Not Applicable

Completed

• Conditions: Progressive Supranuclear Palsy; Parkinson's Disease
• Interventions: Device: active Deep TMS; Device: sham Deep TMS

• Registration Number: NCT02734485
• Lead Sponsor: IRCCS San Raffaele Roma

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.

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 Timeline

• Study Start: 2013-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
active Deep Tms	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.
sham deep tms	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

Name	Time	Method
Change in PSP rating scale 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).	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

Name	Time	Method
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	Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time
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	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).
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	Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time
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	Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time

Trial Locations

Locations (1)

Irccs San Raffaele Pisana; 🇮🇹 Rome, Italy