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Neuromodulation on Motor Function in Parkinson's Disease

Primary Purpose

Idiopathic Parkinsons Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
experimental group - tDCS
Control group (tDCS sham)
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinsons Disease focused on measuring idiopathic PD, Hoehn and Yahr stage I to III, stable medication usage, age 40 to 80 years, absence of cognitive impairment

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    experimental group - tDCS

    Control group (tDCS sham)

    Arm Description

    The tDCS intervention occur at 10 sessions of intervention where electrodes are connected to head specifically in supplementary motor area placed at 2 cm in front of vertex. The clinical stimulator (NeuroConn, Germany) provided the direct current using two silicon-sponge electrodes with a surface area of 35 cm2 (5 × 7cm) embedded in a saline-soaked solution. Immediately after 13 minutes of tDCS application, patient was submitted to gait training three times a week during 4 weeks with visuals cues. The patients were asked to walk along at a 7 meters rubber carpet to at different speed, forward and backward gait, side walk during thirty minutes with three intervals of two minutes. The patient may be at on state of drug administration and the training is applied by another physiotherapist.

    The sham character is ensured by the stimulation time, once the device is programmed to turn off 30 seconds after the beginning of stimulation. The current is switched in ascending ramp mode for 10 seconds until 2 mili ampere and a descending ramp similar also for 10 seconds will be used until the end of stimulation. The sham stimulation is commonly perceived by the patient as the actual treatment and all procedures for the application of the technique should be similar to those adopted for the active stimulation. Immediately after tDCS stimulation, the gait training consisting of a protocol based on sensory cues for 30 minutes is administered three times a week for four weeks. Sham stimulation will be held for 30 seconds in order to mimic the perceived lowering effect of ramp current.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 31, 2014
    Last Updated
    September 24, 2014
    Sponsor
    Universidade Federal de Pernambuco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02250690
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    October 2014 (Anticipated)
    Study Completion Date
    November 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Pernambuco

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group - tDCS
    Arm Type
    Experimental
    Arm Description
    The tDCS intervention occur at 10 sessions of intervention where electrodes are connected to head specifically in supplementary motor area placed at 2 cm in front of vertex. The clinical stimulator (NeuroConn, Germany) provided the direct current using two silicon-sponge electrodes with a surface area of 35 cm2 (5 × 7cm) embedded in a saline-soaked solution. Immediately after 13 minutes of tDCS application, patient was submitted to gait training three times a week during 4 weeks with visuals cues. The patients were asked to walk along at a 7 meters rubber carpet to at different speed, forward and backward gait, side walk during thirty minutes with three intervals of two minutes. The patient may be at on state of drug administration and the training is applied by another physiotherapist.
    Arm Title
    Control group (tDCS sham)
    Arm Type
    Sham Comparator
    Arm Description
    The sham character is ensured by the stimulation time, once the device is programmed to turn off 30 seconds after the beginning of stimulation. The current is switched in ascending ramp mode for 10 seconds until 2 mili ampere and a descending ramp similar also for 10 seconds will be used until the end of stimulation. The sham stimulation is commonly perceived by the patient as the actual treatment and all procedures for the application of the technique should be similar to those adopted for the active stimulation. Immediately after tDCS stimulation, the gait training consisting of a protocol based on sensory cues for 30 minutes is administered three times a week for four weeks. Sham stimulation will be held for 30 seconds in order to mimic the perceived lowering effect of ramp current.
    Intervention Type
    Device
    Intervention Name(s)
    experimental group - tDCS
    Intervention Type
    Device
    Intervention Name(s)
    Control group (tDCS sham)
    Primary Outcome Measure Information:
    Title
    Change on Bradykinesia
    Description
    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 Outcome Measure Information:
    Title
    Change on Cortical excitability
    Description
    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
    Other Pre-specified Outcome Measures:
    Title
    Change on Balance
    Description
    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.
    Time Frame
    This outcome will be measure before ten sessions, 1 and 2 months after ten session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Neuromodulation on Motor Function in Parkinson's Disease

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