CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
t-DCS group +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04620863
NCT04620863N/ACompleted

TRANSCRANIAL DIRECT CURRENT STIMULATION (t-DCS) AS ADD-ON TO NEUROREHABILITATION OF PISA SYNDROME IN PARKINSON DISEASE: A RANDOMIZED CONTROLLED TRIAL

IRCCS National Neurological Institute "C. Mondino" Foundation·interventional·Posted Nov 9, 2020·Updated Nov 13, 2020

In Brief

A clinical study evaluating t-DCS group and Sham group for Parkinson Disease and Pisa Syndrome. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Pisa Syndrome (PS) is a lateral trunk flexion frequently associated to Parkinson's disease (PD). The management of PS is still a challenge for the clinician, because it poorly responds to anti-parkinsonian drugs, and the improvement achieved with neurorehabilitation or botulinum toxin injections tends to fade in 6 months or less. Transcranial direct current stimulation (t-DCS) is a non-invasive neuromodulation technique, with promising results in movement disorders. Aim of our study is to evaluate the role of bi-hemispheric t-DCS as add-on to neurorehabilitation in PS. Twenty-eight patients affected by PD and PS were managed with a 4-week hospital neurorehabilitation programme and randomized to: 1) t-DCS group: 5 daily sessions (20 minutes - 2 mA) with cathode over the primary motor cortex (M1) contralateral to PS, and anode over the M1 cortex ipsilateral to PS; or 2) sham group. Patients were tested with kinematic analysis of trunk movement in static and dynamic conditions, UPDRS-III, FIM, and VAS for lumbar pain rating at hospital admission (T0), at hospital discharge (end of neurorehabilitation - T1), and 6 months later (T2). At T0, the evaluations were completed by an EMG study of trunk muscles activation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 9, 2020
Enrollment StartJan 15, 2019
Primary CompletionAug 15, 2020
Study CompletionSep 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.6 years ago

Interventions

t-DCS groupother

All the participants received daily stimulation sessions for 5 consecutive days, starting from the first Monday after hospital admission (Monday to Friday). The primary motor cortex (M1) was identified using the International 10-20 system for C3 (left M1) or C4 (right M1). For the stimulation, the anode was placed over the primary motor cortex (M1) ipsilateral to the side of trunk deviation, and the cathode was placed over the primary motor cortex (M1) contralateral to the side of trunk deviation (bi-hemispheric stimulation).

Sham groupother

The stimulation setting was exactly the same but the stimulation intensity was set according to a ramping up/ramping down method and delivered only in the first and last 30 seconds of each session. This stimulation paradigm is insufficient to produce a meaningful therapeutic effect, but it is necessary to guarantee the blind condition as it mimics the possible initial tingling sensation associated with active stimulation.