AzTrials
AzTrials

Ischemic StrokeImpACT-24MNCT03551093

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

A study testing ISS SPG stimulation in people with Ischemic Stroke, run by BrainsGate at 4 sites in Georgia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study Population: Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset. Study objectives: 1. Identify the personal stimulation level for each patient based on physiological biomarkers 2. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke
What is being tested?
ISS SPG stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesGeorgia
Study dates
2 Apr 2018to 11 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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).
  • History of SPG ablation ipsilateral to the stroke side.
  • Any condition in the oral cavity that prevents implantation of the INS, such as patient is intubated, orthodontics or non-hygienic condition.
  • Life expectancy < 1 year from causes other than stroke.
  • Participating in any other therapeutic investigational trial within the last 30 days.
  • Known sensitivity to any medications to be used during study.
  • Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include: cardiovascular, vascular, pulmonary, hepatic, renal or neurological (other than acute ischemic stroke), or neoplastic diseases, as determined by medical history, physical examination, laboratory tests, or ECG.
  • Subjects who, in the judgment of the investigator, are likely to be non- compliant or uncooperative during the study.

Trial locations and contacts

4 sites in 1 country.

Georgia4 sites

  • Kutaisi Referral Hospital

    Kutaisi, 4600

  • Rustavi Central Hospital

    Rustavi, 3700

  • First University Clinic

    Tbilisi, 0141

  • Zugdidi Referral Hospital

    Zugdidi, 2100

Other trials in Georgia

About this study

Official title: A Multicenter, Single Arm Trial to Assess Safety and Signal of Efficacy of the Ischemic Stroke System (ISS), as an Adjunct to Standard of Care in Subjects With Mild Acute Ischemic Stroke

Study Population:

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

Study objectives:

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

A Multicenter, Single Arm Trial to Assess Safety and Signal of Efficacy of the Ischemic Stroke System (ISS), as an Adjunct to Standard of Care in Subjects with Mild Acute Ischemic Stroke

Study Duration:

The expected total duration of the study for each subject is up to 10 days as follows:

Enrollment: up to 24 hours Treatment: Implantation, 5 Days of SPG stimulation and Standard of care Final Visit: 7 days after enrollment

Study Population:

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

Study Objectives:

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

Study Design:

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)

Outcome Measures:

Primary Outcome Measures:

  1. The difference in NIHSS between baseline and Day 7 vs. Historical Controls
  2. % of patients with improvement in stroke symptoms (motor and/or sensory deficits) during stimulation

Additional Efficacy Outcome Measures:

  1. Existence of physiologic surrogates of the Personal Stimulation Level
  2. Improvement in stroke symptoms (motor and/or sensory deficits)

Safety Outcome Measures:

  1. Comparative 7-day safety data between the ISS stimulation group of this study and of the ImpACT-24B study:
  2. Incidence of Serious Adverse Events
  3. Implantation Complications
  4. Stimulation-related Adverse Events
  5. 7-day mortality
  6. Neurological deterioration
  7. Symptomatic intracranial hemorrhage (sICH)

Implantation Accuracy Outcome Measures:

  1. % of procedures with positive indication of reaching the sphenopalatine fossa
Conditions
Ischemic Stroke
Being tested
ISS SPG stimulation
Keywords
Ischemic Stroke, Mild Acute Ischemic Stroke, Safety, Signal of Efficacy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ISS SPG stimulationDevice

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

Study groups in NCT03551093
Study groupRoleWhat they receive
Study PopulationExperimentalThe ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa.
Receives: Device: ISS SPG stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 7

  2. % 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).

    Measured: Day 2-5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start2 Apr 2018
  3. Primary completion11 Sep 2018
  4. Study completion11 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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)
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551093
Sponsor's protocol ID
CLP0050613
Acronym
ImpACT-24M
Status last verified
Apr 2019
First submitted
17 May 2018
Last updated
24 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31739771

Questions about this trial

What is this clinical trial studying?

A study testing ISS SPG stimulation in people with Ischemic Stroke, run by BrainsGate at 4 sites in Georgia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NIHSS Assessment (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03551093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in