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

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ClinicalTrials.gov Identifier: NCT04620863
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Pisa Syndrome Other: t-DCS group Other: Sham group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study was a randomized, double-blind, controlled trial
Masking: Double (Participant, Investigator)
Masking Description: Transcranial direct current stimulation (t-DCS) was delivered by an expert technician (V.G.) that was not otherwise involved in the management of the patients. The managing physician as well as the physiotherapist were instead blind to the type of stimulation.
Primary Purpose: Treatment
Official Title: TRANSCRANIAL DIRECT CURRENT STIMULATION (t-DCS) AS ADD-ON TO NEUROREHABILITATION OF PISA SYNDROME IN PARKINSON DISEASE: A RANDOMIZED CONTROLLED TRIAL
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : August 15, 2020
Actual Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tDCS group
Patients randomized to the experimental group were treated with the following parameters: duration of stimulation of 20 minutes per session with a 2 mA intensity delivered at anodal and cathodal levels.
Other: t-DCS group
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 Comparator: Sham Group
The stimulation setting was exactly the same of the experimental group 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.
Other: Sham group
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.




Primary Outcome Measures :
  1. Change of Stat Tot (Stat Bend + Stat Flex) [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    Total postural alteration in the upright standing position (Stat Tot): lateral trunk inclination in the upright standing position (Stat Bend) plus anterior trunk flexion in the upright standing position (Stat Flex).


Secondary Outcome Measures :
  1. Change of Stat Bend [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    Lateral trunk inclination in the upright standing position

  2. Change of Stat Flex [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    Anterior trunk flexion in the upright standing position

  3. Change of ROM Ips [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    Range of Motion (ROM) of trunk bending ipsilateral to the side of trunk deviation

  4. Change of ROM Con [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    Range of Motion (ROM) of trunk bending contralateral to the side of trunk deviation

  5. Change of ROM flex [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    Range of Motion (ROM) of anterior trunk flexion

  6. Change of ROM Ext [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    Range of Motion (ROM) of posterior trunk extension

  7. Change of Total ROM of the trunk [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    ROM Ips + ROM Con + ROM Flex + ROM Ext

  8. Change of The Unified Parkinson's Disease Rating Scale - part III - Motor examination (UPDRS-III) [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    It consists of 18 items (score from 0 to 4). Higher scores are worst otcomes.

  9. Change of Functional Independence Measure (FIM) [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    The Functional Independence Measure (FIM) is an 18-item measurement tool that explores an individual's physical, psychological and social function. FIM scores range from 1 to 7 (1= total assist and 7= complete independence).

  10. Change of Visual analog scale (VAS). [ Time Frame: Change from Baseline at 28 weeks (T2) ]
    Lumbar pain severity was rated according to a 0 to 10 visual analog scale. Zero is no pain and 10 is worst pain.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 80 years;
  • Hoehn and Yahr stage between II and III;
  • Mini-Mental State Examination score above 24;
  • lateral trunk flexion of at least 10° at baseline.

Exclusion Criteria:

  • history of major psychiatric or other neurological conditions;
  • history of back surgery, tumors or infections of the spine, intradural or extradural hematoma, ankylosing spondylitis, spinal stenosis;
  • history of idiopathic scoliosis;
  • botulin toxin treatment in the previous year;
  • any change in dose or regimen of the anti-parkinsonian therapy in the last month before enrolment.

Thirty patients affected by Parkinson' Disease (PD) and Pisa Syndrome (PS) were consecutive enrolled among those attending the Neurorehabilitation Department of the IRCCS Mondino Foundation (Pavia, Italy). Idiopathic PD was diagnosed according to the Movement Disorders Society clinical diagnostic criteria for PD. Pisa syndrome was clinically diagnosed according to the following criteria:

  • a lateral flexion of the trunk with a homogenous angle between sacrum and spinous process of the 7th cervical vertebra;
  • an ipsilateral axial rotation of the trunk around the sagittal axis, that leads to a higher and anterior position of the shoulder contralateral to the side of trunk deviation;
  • the worsening of the postural disorder during standing position, sitting position and gait;
  • the improvement of the postural disorder in supine position.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620863


Locations
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Italy
Neurorehabilitation Department
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Investigators
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Study Director: Cristina Tassorelli, MD IRCCS Mondino Foundation, Pavia
Publications of Results:
Other Publications:

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Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT04620863    
Other Study ID Numbers: Pisa-tDCS
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
Parkinson Disease
Pisa Syndrome
Transcranial direct current stimulation
Additional relevant MeSH terms:
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Parkinson Disease
Syndrome
Disease
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases