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Stroke clinical trials

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NCT ID: NCT00509119 Withdrawn - Stroke Clinical Trials

ICP Waveform Analysis in Stroke Patients

Start date: December 2006
Phase: N/A
Study type: Observational

This is a study on how acute clinical state and final clinical outcome in patients with stroke (exclusive subarachnoid hemorrhage) relate to ICP/ABP-derived pressure waveform parameters recorded during intensive care management.

NCT ID: NCT00508755 Completed - Stroke Clinical Trials

Feasibility and Practice Characteristics of FNS and Gait Robot

Start date: August 2005
Phase: N/A
Study type: Interventional

Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM). Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM. Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM). Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (>6 months after the stroke).

NCT ID: NCT00508521 Completed - Stroke Clinical Trials

Treatment of Hand Dysfunction After Stroke

Start date: January 2007
Phase: N/A
Study type: Interventional

Many stroke survivors exhibit persistent upper limb motor deficits and a non-functional upper limb. There is some promising information that suggests motor learning (ML) in conjunction with functional electrical stimulation (FES; surface FES; nothing implanted; use of a commercially available system) of wrist/finger muscles can significantly enhance the functional level of the upper limb. There have been promising studies showing that some subjects in the chronic phase (greater than 6 months after stroke) responded favorably to combination FES and ML (FES ML). In our pilot studies, FES ML for those in the chronic phase (>12 months) produced statistically significant functional recovery. FES was applied using a commercially available, two-channel FES system, with electrodes applied to the surface of the skin (non-invasive). But if upper limb dysfunction is not immediately treated, that is within the sub-acute phase (less than 6 months) following stroke, the following problems can develop: contractures and other soft tissue changes; chronic pain; and ingrained, abnormal, non-functional movement patterns. The more long-standing these symptoms are, the more resistant to treatment they become. Therefore, it is important to provide promising interventions prior to the onset of chronic symptoms and dysfunction. Those in the sub-acute phase after stroke should be provided with FES ML, in order to more completely restore function for a greater number of stroke survivors. Specific Aims and Hypotheses The goal of this pilot study is to test the feasibility of the proposed treatment in the sub acute phase following stroke. HYPOTHESIS. FES ML for 3hrs/day, five days/week, for 12 weeks will be feasible to implement in the sub-acute phase following stroke (2 -24 weeks). Study Design a. Specific Procedures This is a pilot study to test the feasibility of using FES ML for upper extremity rehabilitation in a sub-acute stroke population. It is a randomized, controlled, single-blind design. Subjects will be 2 - 24 weeks after a single stroke. The control group will receive standard care for upper limb rehabilitation consisting of passive and active exercise, stretching, bracing, and use of adaptive devices. The experimental group will receive the experimental intervention in addition to their standard care. CONTROL GROUP INTERVENTION. The control group will receive the standard medical care prescribed by the primary physician and covered by the subject's health care policy. Standard care will include: soft tissue mobilization; assisted motion exercise; active motion exercise; resistive exercise; task practice; use of assistive devices; and modality applications conventionally prescribed. FES ML INTERVENTION. The research treatment duration will be 3hrs/day, five days per week. The subjects will be present for a fourth hour each day, which will be used for breaks and rest periods that will be interspersed throughout the intervention time. The treatment duration is derived from prior work. We will stimulate muscles in a number of configurations including: wrist extension and finger extension; wrist extension and finger flexion; and wrist extension, finger flexion, and thumb abduction and opposition. Motor learning will include the performance of functional task components and full task practice during the use of FES. FES will be triggered by the patient, the treating therapist, or it will be automatically sequenced by the device according to alternate channel activations, with timings pre-set by the treating therapist. MEASURES. Data will be collected at weeks 1, 6, 12 (end of treatment), and 6 months after the end of treatment. Population The subjects will be sub-acute stroke survivors (2-24 weeks after stroke).

NCT ID: NCT00507806 Terminated - Clinical trials for Acute Ischemic Stroke

Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Start date: March 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

NCT ID: NCT00506818 Completed - Stroke Clinical Trials

Cognitive and Emotional Impairment After Stroke

Start date: February 2007
Phase: N/A
Study type: Interventional

Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular Diseases 2006). The investigators want to include all patients with first ever stroke without significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for one year. At baseline we will make stroke classifications, measure neurological deficits according to NIHSS, evaluate cognitive and emotional function and make registrations of vascular risk factors, including precerebral color duplex scan with measurement of IMT in CCA. The investigators will then randomize the patients into multifactorial vascular-risk-factor-intervention in the hospital or care as usual in the primary health care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate neurological, cognitive and emotional functions, as well as MRI and SPECT.

NCT ID: NCT00504842 Terminated - Clinical trials for Acute Ischemic Stroke

Transcranial Ultrasound in Clinical SONothrombolysis

TUCSON
Start date: December 2006
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

NCT ID: NCT00499902 Terminated - Clinical trials for Acute Ischemic Stroke

Phase 2 Proof-of-Concept Study of the Safety and Efficacy of Alfimeprase to Rapidly Open Arteries and Restore Brain Function Following a Stroke

Start date: June 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to identify a safe and effective bolus dose of intra-arterial/intra-thrombus alfimeprase in acute ischemic stroke (AIS) 3 to 9 hours from symptom onset.

NCT ID: NCT00495248 Active, not recruiting - Stroke Clinical Trials

Thriving, Activity and Social Participation After Stroke

Start date: January 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the effect of a group intervention programme for community dwelling elders with stroke or TIA.The intervention is inspired by a Lifestyle Redesign method developed in the USA. The study is conducted as a multi centre randomized controlled trial. Participants are recruited from five hospitals and the intervention is implemented at six to seven senior centres. The control group is offered physical activity at the senior centre once a week. The intervention group is offered the same with addition of the programme inspired by Lifestyle Redesign. The study will contribute to knowledge whether the intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or TIA.

NCT ID: NCT00494520 Completed - Clinical trials for Traumatic Brain Injury

Cognitive Therapy to Improve Word Finding

Start date: July 2004
Phase: N/A
Study type: Interventional

Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop difficulty finding words. This study compares the effectiveness of two behavior-based programs to improve picture naming ability in these individuals.

NCT ID: NCT00489580 Completed - Stroke Clinical Trials

A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population

Start date: August 2005
Phase: N/A
Study type: Interventional

Study Objectives: 1. To document the safe and effective application of the F.T.M. Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population. 2. To compare functional improvements in hand and UE use achieved with the F.T.M. program as compared to generally applied therapeutic treatment approaches. 3. To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial. 4. To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued.