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

NCT04620863 | Completed

• 1 other identifier: Pisa-tDCS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Pisa Syndrome

Keywords

Parkinson Disease; Pisa Syndrome; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Change of Stat Tot (Stat Bend + Stat Flex)

  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).

  Change from Baseline at 28 weeks (T2)

Secondary Outcomes (10)

• Change of Stat Bend

  Change from Baseline at 28 weeks (T2)

• Change of Stat Flex

  Change from Baseline at 28 weeks (T2)

• Change of ROM Ips

  Change from Baseline at 28 weeks (T2)

• Change of ROM Con

  Change from Baseline at 28 weeks (T2)

• Change of ROM flex

  Change from Baseline at 28 weeks (T2)

Study Arms (2)

tDCS group

EXPERIMENTAL

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

Sham Group

SHAM COMPARATOR

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

Interventions

t-DCS group OTHER

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).

tDCS group

Sham group OTHER

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.

Sham Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Neurorehabilitation Department

Pavia, 27100, Italy

Location

Related Publications (19)

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  PMID: 27425786 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Cristina Tassorelli, MD

  IRCCS Mondino Foundation, Pavia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study was a randomized, double-blind, controlled trial

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 9, 2020
• Study Start: January 15, 2019
• Primary Completion: August 15, 2020
• Study Completion: September 15, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)