Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A)

Stopped early · Not applicable · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.

Key facts

Study ID

NCT03767192

Run by

BrainsGate

People needed

327

Starts

2009-01-01

Expected to finish

2012-03-01

Last updated by the study team

2019-01-28

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: ≥ 18 years and ≤ 85 of both genders.
• Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
• Baseline NIHSS ≥ 7 and ≤ 18
• Ability to initiate treatment within 8- 24 hours from stroke onset.

You may not qualify if…

• Intracranial hemorrhage or hemorrhagic transformation
• Massive stroke
• Acute ischemic stroke in the posterior circulation
• Minor stroke
• Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
• Previous stroke in the last 6 months or pre-existing disability
• Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
• Known cerebral arteriovenous malformation, cerebral aneurysm.
• Clinical suspicion of septic embolus.
• Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
• Serious systemic infection.
• Women known to be pregnant or having a positive or indeterminate pregnancy test.
• Patients with other implanted neural stimulator/ electronic devices (pacemakers).
• Life expectancy < 1 year from causes other than stroke.

Where it is running

• Erlanger Stroke Center — Chattanooga, Tennessee, United States
• Erlangen University Clinic — Erlangen, Germany
• Essen University Clinic — Essen, Germany
• Heidelberg University Clinic — Heidelberg, Germany
• Leipzig University Clinic — Leipzig, Germany
• Munster University Clinic — Münster, Germany
• Hospital Vall d'Hebron — Barcelona, Spain
• Hospital Universitari de Girona — Girona, Spain

Full record on ClinicalTrials.gov

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