Idiopathic Parkinsons Disease Clinical Trial
Official title:
Transcranial Direct Current Stimulation (tDCS) Associated With Gait Training in Improving Motor Function in Parkinson's Disease
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).
| Status | Enrolling by invitation |
| Enrollment | 24 |
| Est. completion date | November 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Universidade Federal de Pernambuco |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change on Balance | Berg Balance scale (BBS) is measured asking to the patient for change posture in sit position for search balance during transferences and standing with one foot at single or double support, with open and closed eyes, narrow support base body, rotation around the own body axis; take up an object at floor and others. This outcome is done using a scale with scores range from 0 to 56. | This outcome will be measure before ten sessions, 1 and 2 months after ten session | Yes |
| Primary | 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. | This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session | Yes |
| Secondary | 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. | 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 | Yes |