TRANSCRANIAL DIRECT CURRENT STIMULATION (t-DCS) AS ADD-ON TO NEUROREHABILITATION OF PISA SYNDROME IN PARKINSON DISEASE: A RANDOMIZED CONTROLLED TRIAL
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change of Stat Tot (Stat Bend + Stat Flex)
Study Overview
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.
Detailed Description
Axial disorders are frequent complications of Parkinson's Disease (PD) and they can lead to postural deformities and balance impairments. The most prevalent postural disorders of PD are represented by camptocormia, antecollis, scoliosis, and Pisa syndrome (PS).
The pathogenesis of these disorders has not yet been completely elucidated, and it is characterized by a complex interlacement between central and peripheral mechanisms.
The first report of PS dates back in 1972, when Ekobm described a case series of three patients who developed a lateral trunk flexion in close temporal relationship with neuroleptics assumption. The roster of drugs associated with an acute/subacute onset of PS is huge and constantly growing, and it includes: antidepressants (mirtazapine, sertraline), cholinesterase inhibitor (rivastigmine, galantamine, donepezil), neuroleptics (tiapride, clotiapine, clozapine, aipiprazole, butyrophenone, paliperidone, quetiapine), dopamine agonists, (pramipexolo, ropinirole, pergolide), lithium, valproic acid, and betahistine. Nonetheless, PS was described as well in patients with neurodegenerative disorders, and in particular in PD and parkinsonism without drugs exposure.
The prevalence of PS is around 8.3% (9.3% in women and 6.4% in men) when calculated in a psychogeriatric population, and it is 8 to 8.8% when populations of PD patients were considered.
Formal diagnostic criteria for PS are not available, indeed the diagnosis is based on the clinical features:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: t-DCS group (Other)
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.
Intervention: Sham group (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Change of ROM Ips(Change from Baseline at 28 weeks (T2))
- Change of Stat Flex(Change from Baseline at 28 weeks (T2))
- Change of Visual analog scale (VAS).(Change from Baseline at 28 weeks (T2))
- Change of Stat Bend(Change from Baseline at 28 weeks (T2))
- Change of Total ROM of the trunk(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))
- Change of ROM Ext(Change from Baseline at 28 weeks (T2))
- Change of The Unified Parkinson's Disease Rating Scale - part III - Motor examination (UPDRS-III)(Change from Baseline at 28 weeks (T2))
- Change of Functional Independence Measure (FIM)(Change from Baseline at 28 weeks (T2))