THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)

NCT03551093 | Completed

• 1 other identifier: CLP0050613
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

Study Population: Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset. Study objectives:

1. 1.Identify the personal stimulation level for each patient based on physiological biomarkers
2. 2.Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; Mild Acute Ischemic Stroke; Safety; Signal of Efficacy

Outcome Measures

Primary Outcomes (2)

• NIHSS Assessment

  The difference in NIHSS between baseline and Day 7 vs. Historical Controls (the historical controls are patients in the control arm in the NINDS trial)

  Day 7

• % of patients with improvement in stroke symptoms during stimulation

  Assessment of improvement in stroke symptoms (motor and/or sensory deficits) before and during stimulation at the Personal Stimulation Level, using a hand dynamometer (Baseline Hydraulic Hand Dynamometers, Fabrication Enterprises Inc, White Plains NY, USA).

  Day 2-5

Other Outcomes (3)

• Increased blood flow in Common Carotid Doppler

  Day 1-5

• Existence of unilateral lacrimation, nasal secretion, and/or facial redness

  Day 1-5

• Improvement in stroke symptoms

  Day 2-5

Study Arms (1)

Study Population

EXPERIMENTAL

The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa.

Device: ISS SPG stimulation

Interventions

ISS SPG stimulation DEVICE

The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa (SPG).

Study Population

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years and ≤ 80 years
• Clinical diagnosis of anterior circulation stroke
• Baseline NIHSS ≥ 1 and ≤ 6 or lacunar stroke of any severity
• Motor and/or sensory deficits
• Ability to initiate treatment within 24 hours from stroke onset
• Signed informed consent from patient him/herself or legally authorized representative if applicable.

You may not qualify if:

• Neuro-imaging evidence of any intracranial hemorrhage or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess, suspect for subarachnoid hemorrhage).
• Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory.
• Clinical signs and symptoms or evidence for a relevant lesion by neuro-imaging of an acute ischemic stroke in the posterior circulation (Vertebral, Basilar and/or Posterior Cerebral Artery territories), including but not limited to brain-stem findings and/or cerebellar findings and/or isolated homonymous hemianopia or cortical blindness.
• NIHSS level of consciousness score ≥ 2.
• Inability to communicate fluently and express symptoms
• Previous motor and/or sensory deficits that will eliminate the ability to identify the response to SPG stimulation
• Patients with bleeding propensity and/or one of the following: INR \> 1.8, prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec., platelets count \< 75×109/L.
• Known cerebral arteriovenous malformation, cerebral aneurysm.
• Seizure at onset.
• Blood glucose concentration \< 60 mg/dL.
• Clinical suspicion of septic embolus.
• Uncontrolled hypertension (systolic \>185 mmHg and/or diastolic \>110 mmHg), demonstrated on each of three repeated measurements taken within one hour regardless of whether or not the patient is taking antihypertensive medications.
• 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).

Sponsors & Collaborators

• BrainsGate: lead

Study Sites (4)

Kutaisi Referral Hospital

Kutaisi, 4600, Georgia

Location

Rustavi Central Hospital

Rustavi, 3700, Georgia

Location

First University Clinic

Tbilisi, 0141, Georgia

Location

Zugdidi Referral Hospital

Zugdidi, 2100, Georgia

Location

Related Publications (1)

• Saver JL, Kharaishvili N, Janelidze T, Beridze M, Zarqua N, Solberg Y, Bornstein NM; IMPACT-24M Trial Investigators. Refined Sphenopalatine Ganglion Stimulator Placement and Intensity Setting to Augment Blood Flow and Neurologic Function. Stroke. 2019 Dec;50(12):3512-3518. doi: 10.1161/STROKEAHA.119.027177. Epub 2019 Nov 19.

  PMID: 31739771 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes the following steps: 1. Screening (day 1) 2. Implantation (day 1) 3. Treatment and symptom assessment (days 1-5) 4. Device Positioning and Removal (day 5) 5. Discharge/Final Visit (day 7-10)

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 11, 2018
• Study Start: April 2, 2018
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (4)