Neuromodulation on Motor Function in Parkinson's Disease
24. september 2014 oppdatert av: 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).
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
24
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Sham-komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change on Bradykinesia
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change on Cortical excitability
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change on Balance
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Forventet)
1. oktober 2014
Studiet fullført (Forventet)
1. november 2014
Datoer for studieregistrering
Først innsendt
31. mars 2014
Først innsendt som oppfylte QC-kriteriene
24. september 2014
Først lagt ut (Anslag)
26. september 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. september 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. september 2014
Sist bekreftet
1. juli 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Parkinson_tDCS_Gait_Impairment
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