Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease
2019年10月28日 更新者：Gad Alon、University of Maryland, Baltimore
Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease
The use of low level electrical stimulation when applied over the head, also called transcranial direct current stimulation (tDCS), is being tested by several groups of researchers to see if tDCS can improve movements of persons with damage to the brain.
The safety and potential benefits of tDCS to children or adults patients who are paralyzed because of brain damage are reported in the medical literature.
In addition, some patients with Parkinson's disease (PD) experience improvement in memory and report better use of the hand after tDCS.
The treatment requires putting electrodes (pads) over the head and sending very small amount of electrical current that the patient may feel as "little tingling".
Application of tDCS takes 20 min.
In this study we wish to test if tDCS application can improve stepping and walking ability of subjects with PD and if the improvement is the same as when walking on treadmill.
We plan to test the subject's ability to step when pulled by a laboratory testing system and also test his/her walking ability.
There will be 3 sessions 7 days apart.
In the first session the subject will be tested then treated for 20 min with tDCS and then tested again.
In the second session the subject will be tested then walk on a treadmill for 20 min then tested again.
In the third session the subject will be tested then walk on the treadmill for 20 min while receiving also tDCS and tested one last time at the end of the session.
Each session will take between 2 and 3 hours.
調査の概要
状態
完了
条件
詳細な説明
Recent advances in non-invasive electrical stimulation technology including transcranial direct current stimulation (tDCS) have provided novel and low risk options to rehabilitate the impaired ability of the central nervous system (CNS) to process sensorimotor information.
Furthermore, tDCS appears to enhance CNS connectivity and there is preliminary evidence indicating that patients with Parkinson's Disease (PD) may experience improvement in working memory, the Unified Parkinson's Disease Rating Scale, simple reaction time and the Purdue Pegboard test.
tDCS is inexpensive, portable and available for repeated home use.
It may provide long-lasting enhancement of cortical activity in part because tDCS is easy to administer frequently and to combine it with other rehabilitation approaches including posture and gait training.
However to date, no study has examined quantitatively the effects of tDCS on posture control and walking ability in patients with PD.
As a first step we plan to identify the immediate effects of tDCS, as well as the added value of tDCS to treadmill exercise training, to improve posture and gait of individuals with PD.
研究の種類
介入
入学 (実際)
10
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21201
- PTRS Research Lab
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Diagnosis of adult onset of PD
- A history of freezing of gait (FOG) as evidence by clinical assessment
- A stable regimen of anti-parkinsonian medications
- Ability to walk at least 10m without assistance
- Ability to walk on a treadmill for 20 minutes
- Personal weight of less than 500 Lb (because the suspension harness over the treadmill is limited to 500 Lb
- Stage 3 of the Hoehn and Yahr disability scale
- A score of >24 on the Mini Mental State Examination
Exclusion Criteria:
- Evidence of any clinically significant functional impairment related to cardiovascular, pulmonary, metabolic, other neurologic or musculoskeletal disease criterial that would preclude participation in training
- Any medical condition that might require other medical or surgical treatment during the study period
- A history of brain surgery or placement of a deep brain stimulator
- Dyskinesias > grade 2 on the Unified Parkinson's Disease Rating Scale (UPDRS)
- Any uncorrected vision or hearing problems that may limit daily activities or communication
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Single Group
10 subjects with Parkinson's Disease receiving tPCS during the first session, treadmill walk, 7-10 days later (second session, and combined tPCS and treadmill 7-10 days week later (third session)
|
We will follow the procedure described by several investigators as safe and effective.
The participant will sit on a standard chair.
Two commercially available surface electrodes will be embedded in an elastic head cup.
Each electrode will be covered with a water soaked absorbent fabric.
One positive (+) electrode will be placed over the primary motor cortex (M1) and pre-motor areas.
One negative (-) electrode will be placed over the skin overlying the contra lateral supra-orbital region.
The electrodes will be connected via 2 leads to a battery powered direct current stimulator.
The stimulator will be programmed to deliver 0.975mA (peak 4mA) over 20 minutes.
The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
Participants will have a combined session with CES while walking on the treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stride Length
時間枠：Data collection occurred before and immediately after each training session
|
Stride Length was measured in centimeters
|
Data collection occurred before and immediately after each training session
|
|
Gait Velocity
時間枠：Data collection occurred before and immediately after each training session
|
Gait Velocity was measured in meters per second
|
Data collection occurred before and immediately after each training session
|
|
Cadence
時間枠：Data collection occurred before and immediately after each training session
|
Cadence was measured in steps per minute
|
Data collection occurred before and immediately after each training session
|
|
Number of Steps to Regain Balance
時間枠：Data collection occurred before and immediately after each training session
|
Steps to regain balance were measured by the number of steps needed to recover standing balance.
The steps were counted using a custom software of the motion capture system.
|
Data collection occurred before and immediately after each training session
|
|
First Step Length
時間枠：Data collection occurred before and immediately after each training session
|
First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step.
Measurements were taken separately for forward and backward first step.
|
Data collection occurred before and immediately after each training session
|
|
First Step Velocity
時間枠：Data collection occurred before and immediately after each training session
|
First step velocity was measured in meters per second
|
Data collection occurred before and immediately after each training session
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Gad Alon, PhD, PT、University of Maryland, Baltimore
- 主任研究者：Mark W Rogers, PhD, PT、University of Maryland, Baltimore
- 主任研究者：Lisa Shulman, MD、Univeristy of Maryland, Baltimore
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年1月1日
一次修了 (実際)
2011年6月1日
研究の完了 (実際)
2011年6月1日
試験登録日
最初に提出
2010年3月19日
QC基準を満たした最初の提出物
2010年4月8日
最初の投稿 (見積もり)
2010年4月9日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月30日
QC基準を満たした最後の更新が送信されました
2019年10月28日
最終確認日
2019年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。