Stroke & Neurosurgery Clinical Trials

Sleep for Stroke Management And Recovery Trial (Sleep SMART)

Principal Investigator: Sophia Sundararajan, MD, PhD

Study Purpose: This is a study being done to determine if treatment of obstructive sleep apnea with positive airway pressure after ischemic stroke or transient ischemic attack (TIA) reduced recurrent stroke, acute coronary syndrome, and death within six months of the initial stroke. It is also testing whether treatment of obstructive sleep apnea shortly after the ischemic stroke improves stroke recovery within three months. Automatically-adjusting positive airway pressure, aCPAP, will be tested against “usual care” for stroke patients with obstructive sleep apnea. Patients who meet criteria and consent to the study will be enrolled for six months.

Basic Inclusion Criteria:

• > 18 yrs 
• TIA with ABCD2 ≥4 or ischemic stroke within the prior 14 days
• independent ADLs prior to index stroke
• not currently using positive airway pressure or have not within one month of stroke

Study Coordinator:  Mary Andrews 216-844-2386

GTX Study - Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients Hospitalized for Aneurysmal Subarachnoid Hemorrhage (aSAH)

Principal Investigator: Abhishek Ray, MD

StudyID:STUDY20230938

Study Purpose: The purpose of this study is to evaluate the safety and tolerability of GTX-104 (Nimodipine Injection for IV Infusion) compared to oral nimodipine..

Basic Eligibility Criteria:  

• Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH) based on CT scan and angiography (computed tomography angiography [CTA], magnetic resonance angiography [MRA], or digital subtraction angiography [DSA]).
• Hunt and Hess score from I to V just prior to randomization
• Patient was taking a statin drug at the onset of the qualifying/index ICH
• Able to start IP within 96 hours from the onset of aSAH.

Study Coordinator:  Mary Andrews 216-844-2386

StATins Use in intRacereberal hemorrhage patieNts (SATURN)

Principal Investigator: Abhishek Ray, MD

Study Purpose: The purpose of this study is to find out if it is better to continue or discontinue statin drug on the risk of intracerebral hemorrhage (ICH) recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar ICH while taking a statin drug.

Basic Eligibility Criteria:  

• Spontaneous lobar ICH within 7 days prior to randomization confirmed by CT or MRI scan.
• Lobar ICH will be defined as ICH involving cortical or subcortical locations and situated ≥1 cm from the body of the ipsilateral lateral ventricle and not originating from any of the following deep structures (thalamus, putamen, globus pallidus, caudate, or internal capsule).
• Patient was taking a statin drug at the onset of the qualifying/index ICH
• Randomization must be carried out within 7 days of the onset of the qualifying ICH

Study Coordinator:  Mary Andrews 216-844-2386

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery (ASPIRE)

The purpose of this research study is to compare the effects of apixaban (also known as Eliquis®) with aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

A Transcranial Direct Current Stimulation For Post-Stroke Motor Recovery A Phase II Study (TRANSPORT2)

Study Purpose: The main aim is to find out if non-invasive brain stimulation combined with an established rehabilitation therapy improves arm weakness. The stimulation technique being used is called transcranial direct current stimulation (tDCS). The treatment uses weak electrical currents to stimulate specific parts of the brain. The rehabilitation therapy is called modification Constraint Induced Movement Therapy (mCIMT). Eligible participants will be randomly assigned to receive either high dose, low dose, or no dose of stimulation. Participation in the study will be approximately 4 months. This includes two hours of therapy for 10 days over the course of two weeks.  

TRANSPORT2 is a clinical trial for patients who have suffered their first ever ischemic stroke within the last 6 months, resulting in arm weakness. The information learned from TRANSPORT2 may help determine the best treatment for stroke recovery. 

Main Eligibility Criteria:

• Age 18– 80 years old
• First ever ischemic stroke that occurred in the last 6 months
• One sided arm weakness as a result of the stroke
• You have NOT received Botulinum toxin (BOTOX) injections in the last 3 months
• No history of seizures
• No pacemaker or any metallic parts in your body

TRANSPORT2 is funded by the National Institute of Neurological Disorders and Stroke. More information can be found on https://clinicaltrials.gov by searching the keyword TRANSPORT2

Study Contacts:

• Linda Colosimo 216-791-3800 x 65273, email address: linda.colosimo@va.gov 
• Ahlam Salameh 330-634-4989,  email address : Ahlam.Salameh@va.gov
• Svetlana Pundik 216-791-3800 x 63732, email address: Svetlana.Pundik@va.gov

Drs. Martha Sajatovic and Carolyn Harmon Still are conducting a randomized controlled trial (RCT) that uses a psychoeducational approach to reduce the unacceptably high rates of stroke and stroke complications in African-American men. It is a person-centered, holistic intervention that takes advantage of existing strengths in African-American families and/or communities. TEAM uses peer educator dyads (PEDs) to provide support and model behaviors. The PED consists of an AA man peer educator with experience in managing his own stroke risk and his care partner. A care partner is a family member, friend or other individual who is important in the AA man’s stroke recovery.

Study Title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis

Principal Investigator:  Vikram Kashyap, MD (Vascular Surgery)

Basic Eligibility Criteria:

• ≥70% extracranial carotid stenosis by angio or ≥70% by duplex ultrasound defined by peak systolic velocity of at least 230 cm/s AND at least ONE of the following:
  • End diastolic velocity ≥ 100 cm/s, or
  • Internal carotid/common carotid artery PSV ratio ≥4.0 or
  • ≥70% stenosis  by CTA or
  • ≥70% stenosis by MRA
• No ipsilateral stroke or TIA ≥ 180 days of randomization
• No atrial fibrillation that requires anticoagulation
• mRS of 0 or 1 at time of informed consent

Study Coordinator: Carla Kinder at 216-844-2988

Principal Investigator: Collin Labak, MD
StudyID# STUDY20220068

Study Purpose: his research study aims to assess the effects of a novel musical intervention on sense of patient-physician alliance in patients undergoing neurosurgical bedside procedures.

Basic Eligibility Criteria:

• Adult patients >18 years of age receiving treatment at UHCMC main campus.
• Patients being treated for a neurologic illness by the neurosurgery team.
• Patients with capacity to consent to procedures.
• Patients undergoing lumbar punctures, lumbar drains, arterial lines, and central venous catheters, and percutaneous fluid collection taps.
• Patients who have the physical and cognitive ability to fill out written surveys.
• Patients undergoing indicated elective or urgent procedures where inclusion of a ten minute delay would reasonably not be expected to affect patient care.

Study Coordinator: Please contact Mary Andrews for more information at Mary.Andrews@UHhospitals.org or 216-844-2386.

Principal Investigator: Richard Wilson, MD
IRB# IRB16-00172

Study Purpose: This study will evaluate the effect of therapy and electrical stimulation in three different combinations to reduce post-stroke shoulder pain. Study participants will receive either electrical stimulation that will make their shoulder muscles contract, physical therapy for shoulder pain, or a combination. The treatment period lasts 4 weeks and there is a 6 month follow-up period.

Basic Eligibility Criteria:

• 3 month post stroke
• shoulder pain > 3 months duration in the weak shoulder after stroke
• moderate to severe pain in the shoulder,

Study Coordinator: Krissy Hansen, PT for information at khansen1@metrohealth.org or 216-957-3584

Principal Investigator: Jayme Knutson, PhD
IRB #: IRB17-00884

Study Purpose:  Researchers at University Hospitals in partnership with MetroHealth Medical Center, Case Western Reserve University, and the Cleveland Clinic are conducting a study with individuals who have weak or paralyzed arm and hand muscles resulting from a stroke. This research study will compare the effects of three therapies to improve arm and hand movement and function.

All participants will receive therapy for 12 weeks that will include both self-administered exercise at home and one-on-one therapy at the research lab at the Old Brooklyn MetroHealth Health Center. 

Basic Eligibility Criteria:

• < 2 years post stroke
• Have a weak arm and hand
• Have enough arm movement to move weak arm across a table
• Have no severe shoulder or hand pain

 Study Coordinator: Amy Friedl OTR/L for information at afriedl@metrohealth.org or 216-957-3581

Study Purpose: Researchers at University Hospitals in partnership with Louis Stoke Cleveland Department of Veterans Affairs Medical Center, MetroHealth Medical Center and Cleveland Clinic are conducting a study with individuals who have weak or paralyzed arm and hand muscles resulting from a stroke.  The research study will compare the effects of 2 electrical stimulation treatments to the hand, along with hand therapy video games.  The study will determine if the new treatment improves hand and arm movement or changes how the brain works during hand movement. 

Basic Eligibility Criteria:

• 6 month post stroke
• Have a weak arm and hand
• Have enough arm movement to move weak arm across a table
• Have no severe shoulder or hand pain

Study Coordinator: Amy Friedl OTR/L for information at afriedl@metrohealth.org or 216-957-3581

Principal Investigator: David Cunningham
SPARTA ID: STUDY00000229

Study Purpose: The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.

Main Eligibility Criteria: Individuals who have had a stroke more than 6 months ago and less than 2 years ago and continue to have poor hand function are being asked to participate in this research study.

Study Coordinator: Amy Friedl 216-957-3581

Principal Investigators: Dr Sepideh Amin-Hanjani and Dr. Amanda Opaskar

Study Purpose: The purpose of this research study is to determine if the investigational drugs, rivaroxaban or ticagrelor, or both are superior to the drug clopidogrel when it comes to lowering the rate of ischemic stroke, intracerebral hemorrhage, or vascular death 1 year after having a qualifying stroke.

Main Eligibility Criteria: Acute focal symptoms or signs of any duration associated with imaging, pathological, or other objective evidence of arterial infarction OR clinical evidence of cerebral, spinal cord, or retinal focal arterial ischemic injury based on symptoms persisting >24 hours that occurred within 30 days prior to randomization Index stroke in 1 above is attributed to 70-99% stenosis (or flow gap on MRA) of a major intracranial artery (carotid artery, middle cerebral artery (M1 or M2), vertebral artery (V4), basilar artery, posterior cerebral artery (P1), or anterior cerebral artery (A1)) documented by CTA, MRA, or catheter angiography. Modified Rankin Scale score of ≤ 4, at time of consent. Ability to swallow pills.

Study Coordinator: Mary Andrews (440 496 7905)

ClinicalTrials.gov ID: NCT05047172