Neuromodulation on Motor Function in Parkinson's Disease
2014년 9월 24일 업데이트: 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).
연구 개요
상태
알려지지 않은
상세 설명
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.
연구 유형
중재적
등록 (예상)
24
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
|
가짜 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change on Bradykinesia
기간: This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change on Cortical excitability
기간: 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
|
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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change on Balance
기간: This outcome will be measure before ten sessions, 1 and 2 months after ten session
|
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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 9월 1일
기본 완료 (예상)
2014년 10월 1일
연구 완료 (예상)
2014년 11월 1일
연구 등록 날짜
최초 제출
2014년 3월 31일
QC 기준을 충족하는 최초 제출
2014년 9월 24일
처음 게시됨 (추정)
2014년 9월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 9월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 9월 24일
마지막으로 확인됨
2014년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- Parkinson_tDCS_Gait_Impairment
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .