Neuromodulation on Motor Function in Parkinson's Disease

Universidade Federal de Pernambuco24 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Idiopathic Parkinsons Disease

Interventions

experimental group - tDCSDEVICE

Control group (tDCS sham)DEVICE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change on Bradykinesia

This outcome will be measure in three different moments of evaluation and at all interventions (sessions) days - before and after intervention. Beyond these evaluations, the voluntairs will be evaluate at: T1- before ten sessions; T2- Immediately after ten sessions and T3- after a period of 1 month without intervention.

Time frame: This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session

Secondary Outcomes

Change on Cortical excitability

The secondary outcome measures will be done using amplitude of Motor Evoked Potential (MEP) and rest Motor Threshold (rMT) elicited by transcranial magnetic stimulation (TMS) by means of Neuro-MS device of Neurosoft.

Time frame: 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

Data from ClinicalTrials.gov

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