Clinical trial NCT02250690: Neuromodulation on Motor Function in Parkinson's Disease
Official title: Transcranial Direct Current Stimulation (tDCS) Associated With Gait Training in Improving Motor Function in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Parkinsons Disease
Keywords: idiopathic PD
Hoehn and Yahr stage I to III
stable medication usage
age 40 to 80 years
absence of cognitive impairment
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the present study was to analyze the effect of consecutive sessions of Transcranial direct current stimulation associated to kinesiotherapy about gait performance of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min) and stride length (m). The secondary outcome is motor cortex excitability which is analyzed by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor evoked potential amplitude (MEP) and rest motor threshold (rMT).

Detailed description: This study consist by interventions involving screening followed by evaluation, where volunteers were subjected to the many tests: history, session III of the Unified Scale Modified Parkinson's Disease - Unified Parkinson 's Disease Rating Scale, Ten meters walk test - Walk Test 10 meters and shoot gait, (using Studio Version 8 software). On the same day, the subjects underwent assessment of brain excitability to determine motor threshold and amplitude of the motor evoked potential (MEP). The randomization of the volunteers was conducted by an external search through opaque envelopes ordered according to a random distribution. The subjects were divided into two groups : control group , this group submitted to Transcranial Stimulation sessions a sham Continuous Current (sham tDCS) and gait training , and Experimental group, subjected to the stimulation by Transcranial Direct Current sessions (active tDCS ) and gait training.

Eligibility criteria: Inclusion Criteria:

* Main eligibility criteria were idiopathic Parkinson's disease
* Both sex
* Hoehn and Yahr stage I to III
* Showing mild to severe gait disturbances
* Stable medication usage
* Age 40 to 80 years
* And absence of cognitive impairment and disorders interfering with participation in cueing therapy.

Exclusion Criteria:

* Presence of chronic disabling pathologies of lower limb
* Presence of pacemaker or severe cardiovascular conditions
* A history of tumor, prior neurosurgical brain
* Intervention, or severe cardiovascular conditions, including the presence of a pacemaker
* A diagnosis of epilepsy or major psychiatric disorders.
* Participants with other neurological, muscular, or psychiatric disorders (e.g. peripheral neuropathies, uncorrected visual problems, hearing problems, vestibular dysfunction, stroke, seizure, migraine, or frequent severe headaches) were excluded.
* Participants with surgical implants, significant postural tremor, dyskinesia, severe freezing or dementia were also excluded.

Primary outcomes:
measure: Change on Bradykinesia
timeFrame: This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session
Secondary outcomes:
measure: Change on Cortical excitability
timeFrame: The evaluation occur in 3 different moments: before and after each session, after a period of 1 month without intervention. This outcome will be measure at all intervention and evaluation days
Other outcomes:
measure: Change on Balance
timeFrame: This outcome will be measure before ten sessions, 1 and 2 months after ten session
Locations:
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