Observational Study of Ischaemic Stroke

NCT01859572 | Completed

• 1 other identifier: RN-CS-0001
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for this study is to facilitate future Phase II/III clinical trials and improve outcome for patients suffering residual disability after an ischaemic stroke. Main study objectives are to document and better define the prognostic characteristics of residual disability in patients following an ischaemic stroke, to inform the design of small efficient Phase II studies when screening potentially efficacious interventions for signals of activity which merit further development and to establish a pool of patients who may be approached to participate in future clinical trials in the ischaemic stroke setting.

Conditions

Stroke; Motor Activity

Keywords

Stroke; Cerebral Infarction; Brain Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischaemia

Outcome Measures

Primary Outcomes (4)

• Action Research Arm Test (ARAT)

  6 months

• National Institute of Health Stroke Scale (NIHSS)

  6 months

• modified Rankin Scale (mRS)

  6 months

• Barthel Index (BI)

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The group consists of consenting patients who survive the first 7 days following their first ischaemic stroke in participating stroke units

You may qualify if:

• Capacity to give informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to physical impairments
• Clinical diagnosis of cortical and/or subcortical ischaemic stroke in an area perfused by the middle cerebral artery (i.e. stroke due to ischaemia resulting in infarct located in the basal ganglia, internal capsule or corona radiata)
• Survived first 7 days following ischaemic stroke.
• A motor handicap 7 days after the onset of the ischaemic stroke, which includes as a minimum, the inability to extend an arm to a horizontal position with the palm upward against gravity and to maintain the arm extended horizontally against gravity without obvious downward drift for 30 seconds.

You may not qualify if:

• Prior history of stroke resulting in permanent, moderate to severe disability (i.e. Rankin Scale greater than 2) (other than the presenting ischaemic stroke)
• Stroke due to haemorrhage
• History of neurological or other disease resulting in significant functional impairment of the paretic arm impairing potential ability to pick up, lift and place a 2.5 cm3 block (e.g. Parkinson's disease, motor neuron disease, arthritis, Dupuytren's contracture or fixed anatomical abnormality)
• Patient with a severe comorbid disorder, not expected to survive more than 12 months
• Considered unlikely to be able to attend for all follow-up visits

Sponsors & Collaborators

• ReNeuron Limited: lead

Study Sites (1)

Glasgow Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Motor Activity; Cerebral Infarction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Behavior; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 22, 2013
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

GB (1)