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Enhanced Motor Recovery Using Serotonergic Agents in Stroke

2016년 12월 26일 업데이트: T. George Hornby, Shirley Ryan AbilityLab

The information derived from this study will be critical to establishing appropriate rehabilitative interventions post-stroke. In particular, traditional use of pharmacological agents to alter motor function post-stroke is directed primarily at reducing the "positive" signs following upper motor neuron lesion, in particular spasticity, or enhanced, velocity-dependent stretch reflex responses to imposed stretch. While pharmacological management of spasticity certainly suppresses clinical and quantitative measures of hypertonia, there is little improvement in functional performance. In contrast, preliminary data on the administration of 5HT agents following neurological injury indicates an increase in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to maximize function following stroke despite potential, short-term increases in spastic motor activity may improve therapeutic intervention strategies. The general objective of this study is therefore to:

  1. quantify the effects of short-term SSRI administration on voluntary and spastic motor behaviors in individuals with chronic spastic hemiparesis,
  2. identify the changes in impairments and functional recovery of walking ability during BWSTT with the presence or absence of SSRIs.

연구 개요

상세 설명

Walking ability post-stroke is characterized primarily by reduced walking speed and endurance and impaired postural stability which limits functional and societal reintegration. Decreased over ground walking speed is a result of decreased cadence, decreased stride length and increased non-paretic single limb stance duration. Mechanisms underlying reduced velocity are thought to include weakness in the paretic limb, particular hip flexor and plantarflexor strength, but may also be linked spastic motor behaviors and loss of inter- and intra-limb coordination. Rehabilitation efforts to improve strength and muscle coordination patterns during hemiparetic gait may improve gait quality and velocity and therefore improve performance of activities of daily living.

To improve gait performance and functional outcomes following neurological injury, rehabilitation efforts have focused on re-establishing normal walking patterns . Towards this end, the use of body-weight supported treadmill training (BWSTT) has demonstrated significant improvement in walking capability in individuals post-stroke and spinal cord injury . By supporting a portion of a subject's body weight over a treadmill and providing manual facilitation from therapists, previous research has demonstrated improvements in temporal-spatial gait patterns, including gait velocity , endurance (Macko 2005), balance , and symmetry. Importantly, the changes in impairments and functional limitations observed with intensive BWSTT are often greater than that achieved during conventional or lower intensity physical therapy. Given these benefits, particularly in those who require substantial walking assistance following stroke various robotic locomotor retraining devices have been developed to facilitate practice of "kinematically correct" stepping patterns to improve the consistency and duration of treadmill training.

While the changes observed following BWSTT are statistically and functionally significant, it remains unclear is the benefits of such intensive training paradigms are optimized. Specifically, across many larger studies in subjects with chronic stroke (i.e., those > 6 mo. post-injury), mean increases in walking speed range between 0.09 m/s to 0.15 m/s following 1-6 mos. of training. Even in current trials investigating changes in over ground walking speed in robotic- vs. therapist-assisted BWSTT, mean improvements over at least 18 subjects in each group vary from 0.07 to 0.13 m/s, respectively (please see Preliminary work: Pilot Study 1). While again statistically significant, such changes represent an approximate 10% improvement in gait speed as compared to healthy adults (Perry 1992).

To enhance the benefits of intensive BWSTT, many investigators continue to search for combined interventions to augment recovery. One potential adjunct that has received attention is the use of pharmacological agents. For example, anti-spastic medications (e.g., benzodiazepine, baclofen, tizanidine) have been used for decades (to reduce the presence or severity of involuntary, spastic reflexes in patients with stroke. Spasticity has traditionally been thought to be a primary limitation to functional mobility post-stroke, although this premise has been questioned recently . Indeed, many pharmacological agents are effective in reducing spastic motor behaviors although evidence for improvements in function following use of these agents post-stroke is limited. In addition, some evidence suggests that these agents reduce maximal voluntary strength and can impair learning of motor tasks.

New evidence has emerged of a potentially powerful role of excitatory or facilitative modulatory agents in the treatment of motor impairments post-stroke. Based primarily on evidence from experimentally induced lesions in mammals, the application of monoaminergic (i.e., serotonin [5HT] and norepinephrine [NE]) agents excite vs. depress spinal or cortical excitability have gained momentum. In individuals post-stroke, for example, the use of amphetamines (directed primarily through NE pathways) had generated substantial interest as an adjunct to physical therapy interventions, although recent data may suggest no benefit from this agent. Further, the use of amphetamines may enhance the risk of cerebral or coronary vascular disease, which is already compromised in this patient population, and therefore limit the use of these agents in clinical practice.

In contrast, 5HT agents have also been shown to enhance spinal and/or cortical excitability, and may accelerate locomotor recovery following neurological injury when appropriate physical interventions are provided . In humans post-stroke, one study has demonstrated enhanced motor performance and cortical activity following a single dose of SSRIs. In another study of sub-acute stroke, SSRIs and not selective NE reuptake inhibitors improved function during inpatient rehabilitation. Interestingly, a small case report indicates a strong increase in spasticity following use of 5HTergic anti-depressive agents, indicating that both spinal and cortical excitability may contribute to altered motor function. Such findings have been replicated here (please see Preliminary work: Pilot Study I, although certainly require further assessment.

While the above findings are preliminary, two important questions arise. First, if both spastic and voluntary lower extremity activity are simultaneously altered following administration of commonly used anti-depressive medications, how does the relation between these variable alter motor function? Echoing tothers, how important is the prevalence of spasticity to impaired motor function post-stroke? Secondly, can the increased excitability of both spinal and cortical systems following SSRI accelerate motor recovery and the effectiveness of intensive physical rehabilitation strategies, as shown in reduced preparations? Such data are important for health care professionals treating individuals with neurological injury to: A) understand the previously unknown modulation in reflex or voluntary function following a seemingly innocuous agent; and, to B) provide the optimal neural excitability to accelerate motor performance and recovery post-injury.

연구 유형

중재적

등록 (실제)

30

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Illinois
      • Chicago, Illinois, 미국, 60611
        • Rehabilitation Institute of Chicago

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • unilateral supratentorial stroke
  • MMSE > 22
  • > 6 months stroke duration
  • < 0.9 m/s gait speed overground

Exclusion Criteria:

  • lower extremity contracture
  • osteoporosis
  • Cardiovascular/metabolic/respiratory instability
  • previous central/peripheral nerve injury
  • concurrent medications interacting with SSRIs

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: 크로스오버 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SSRI
SSRI alone or with training
SSRI alone or with training
다른 이름들:
  • 에스시탈로프람
위약 비교기: Placebo
Placebo alone or with training
Placebo alone or with training

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Peak treadmill speed
기간: 4 weeks
4 weeks

2차 결과 측정

결과 측정
기간
overground walking speed
기간: 4 weeks
4 weeks

기타 결과 측정

결과 측정
기간
gait kinematics
기간: 4 weeks
4 weeks
EMG activity
기간: 4 weeks
4 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Thomas G Hornby, Shirley Ryan Abilitylab

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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

2004년 12월 1일

기본 완료 (실제)

2012년 1월 1일

연구 완료 (실제)

2012년 1월 1일

연구 등록 날짜

최초 제출

2012년 12월 14일

QC 기준을 충족하는 최초 제출

2012년 12월 14일

처음 게시됨 (추정)

2012년 12월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 12월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 12월 26일

마지막으로 확인됨

2012년 12월 1일

추가 정보

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. .

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