Clinical Trial: Deep TMS for the Treatment of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Use of Deep TMS for the Treatment and Rehabilitation of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
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 Summary: 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.
Sponsor: IRCCS San Raffaele
Current Primary Outcome: 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). ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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).
- 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
- 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
- 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
Original Secondary Outcome: Same as current
Information By: IRCCS San Raffaele
Dates:
Date Received: March 31, 2016
Date Started: October 2013
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016
