Neuromodulation on Motor Function in Parkinson's Disease
24 septembre 2014 mis à jour par: Adriana Carla Costa Ribeiro Clementino, Universidade Federal de Pernambuco
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).
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
24
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: experimental group - tDCS
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.
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Comparateur factice: Control group (tDCS sham)
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change on Bradykinesia
Délai: This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session
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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.
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This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change on Cortical excitability
Délai: 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
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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.
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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
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change on Balance
Délai: This outcome will be measure before ten sessions, 1 and 2 months after ten session
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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.
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This outcome will be measure before ten sessions, 1 and 2 months after ten session
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2013
Achèvement primaire (Anticipé)
1 octobre 2014
Achèvement de l'étude (Anticipé)
1 novembre 2014
Dates d'inscription aux études
Première soumission
31 mars 2014
Première soumission répondant aux critères de contrôle qualité
24 septembre 2014
Première publication (Estimation)
26 septembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 septembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 septembre 2014
Dernière vérification
1 juillet 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Parkinson_tDCS_Gait_Impairment
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