University of Cincinnati Stroke Recovery Research

TeamTamilyn Bakas, PhD, RN, FAHA, FAAN

Professor and Jane E. Procter Endowed ChairUniversity of Cincinnati College of Nursing

University of Cincinnati Stroke RecoveryTeam•The University of Cincinnati Stroke Recovery Research

Team works to better understand how stroke survivors andfamilies recover from stroke and how to maximize strokerecovery.

Oluwole (Wole) Awosika, MD, College of MedicineTamilyn Bakas, PhD, RN, FAHA, FAAN, College of NursingPierce Boyne, PT, DPT, PhD, NCS, College of Allied Health SciencesSheva Coleman, MD, College of MedicineAimee Dietz, PhD, CCC-SLP, College of Allied Health SciencesKari Dunning, TP, PhD, College of Allied Health Sciences

Objectives

•Discuss ongoing stroke recovery research studies beingconducted by an interdisciplinary research team.

•Learn about study topics that include walking recovery, arm

and hand function, language and speech recovery, mood anddepression, hemineglect, life-management, and familycaregiver support.

Stroke Recovery

Neurorecovery Lab

Co-DirectorsAimee Dietz, PhD, CCC-SLPPierce Boyne, PhD, DPTWole Awosika, MD

TEAM-Sheva Coleman, MD-Tami Bakas, PhD-Elaine Miller, PhD-Kari Dunning, PhD-Valerie Hill, PhD, OTR/L-Aimee Dietz, PhD, CCC-SLP-Pierce Boyne, PhD, DPT-Wole Awosika, MD

LocalRecoveryStudies

Locomotion & ExercisePhysiology Section

Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover

Walking Post-StrokeHIT-Stroke Trial

NICHD/NCMRR R01HD093694• Aim 1: Determine the optimal locomotor training intensity

for eliciting immediate improvements in walking capacityamong chronic stroke survivors

• Aim 2: Determine the minimum locomotor trainingduration needed to maximize immediate improvements inwalking capacity

3-site phase II trial• University of Cincinnati (overall PI: Pierce Boyne PT, DPT, PhD, NCS)• Co-Is: Kari Dunning PT, PhD, Daniel Carl PhD, Oluwole Awosika MD,

Jane Khoury PhD, Brett Kissela MD, MS• University of Delaware (site PI: Darcy Reisman PT, PhD)• University of Kansas Medical Center (site PI: Sandra Billinger PT, PhD)

• Fifty participants• >6 months post stroke with residual gait impairment• Randomize to moderate-intensity aerobic training or high-

intensity interval training• 45 minutes, 3x/week for 12 weeks• Blinded assessment of:• walking function, aerobic fitness and quality of life• Baseline and after 4, 8 & 12 weeks of training

Backward Locomotion +TranscutaneousSpinal Direct Current Stimulation (BLT+tsDCS Study)Funding Source: UCGNIPI: Oluwole Awosika, MDDesign: Randomized, double-blinded pilot study

Study Aims:1. To determine the safety, tolerability, and feasibility of

backward locomotor treadmill training (BLT) in chronicstroke patients with gait impairment. *Target enrollment(n=30).

2. To determine if BLT can lead to improvement in over-ground forward walking.

3. To obtain pilot data on the efficacy of transcutaneousspinal direct current stimulation (tsDCS) in enhancing theeffects of BLT.

BLT+tsDCS Study Status

*Goal: 70% of enrolledparticipants will complete thestudy

Start Date: September 5, 2017

Projected End Date: December 17,2018

ClinicallyMeaningfulDifference

Median (interquartile range)

Outcomes: Safety and tolerability questionnaire, 10MW speed,Walking Capacity (6 minute walk test), PHQ9, M-Ashworth

Neurorecovery LaboratoryLanguage Recovery & CommunicationLanguage Recovery & Communication

TechnologyTechnology

Aimee Dietz, PhD, CCC-SLPElisheva Coleman, MD

Feasibility Study: Use of AAC for Language Recovery• The purpose of this study was to pilot a novel

AAC intervention— and compare it to usualcare—on the communicative effectiveness of12 PWA during a narrative discourse task.

Figure 4. Blue = Pre-Treatment; Red = PostTreatment. LI values < -0.1 indicates right-lateralization and LI > 0.1 indicate left-lateralization; -0.1 < LI ≤ 0.1 representbilateral, or symmetric language.

AAC-induced Language Recovery: A Unique Neurobiological Mechanism?

Left = Visual Word Form AreaRight = Object Recognition

Object & Face Recognition

Co-InvestigatorsJennifer Vannest, PhD, CF-SLP; Weihong Yuan, PhD;Jennifer Vannest, PhD, CF-SLP; Weihong Yuan, PhD;Mekibib Altaye, PhD; Elisheva Coleman, MDMekibib Altaye, PhD; Elisheva Coleman, MDConsultantsJerzy Jerzy Szaflarski, MD, PhD; Krista Szaflarski, MD, PhD; Krista WlikinsonWlikinson, PhD, PhD

R15(NIH-NIDCD): A Preliminary Study of theA Preliminary Study of theNeurobiology of AAC-Induced Language Recovery inNeurobiology of AAC-Induced Language Recovery inPost-Stroke AphasiaPost-Stroke Aphasia• Aim 1: Determine the therapeutic effect of providing AAC treatment,

designed to evoke language recovery, to people with chronic, post-stroke aphasia.

• Aim 2: Evaluate underlying changes in functional and structuralneuroanatomy associated with AAC treatment.

• Exploratory Aim: Identify treatment responder subgroups based ondata collected in Aim 1 and Aim 2.

!!!LAUNCHES!!!LAUNCHESTODAY!!!TODAY!!!

Aimee Dietz, PhD, CCC-SLPAimee.dietz@uc.edu

Adapted Yoga Therapy for Stroke Survivorswith

Aphasia and Their Caregivers1. Develop and test the feasibility of anadaptive yoga program for peoplewith aphasia and caregivers.

2. Through this unique approach toThrough this unique approach toPWCA-caregiver yoga therapy, thePWCA-caregiver yoga therapy, theteam will identify outcomes andteam will identify outcomes andassociated measures that will bestassociated measures that will bestcapture treatment-related changes.capture treatment-related changes.

3. PROJECT BRIDGE: PROJECT BRIDGE: PCORIMEETINGCo-PI: Mike McCarthy, PhDMike McCarthy, PhD

Co-Is: Tami Bakas, PhD; Rachel Gleason,Tami Bakas, PhD; Rachel Gleason,DPT; Kari Dunning, PhDDPT; Kari Dunning, PhD

Student-Led Projects: Chitrali Mamlekar1. AAC on Inpatient Rehabilitation Units: The SLPs’1. AAC on Inpatient Rehabilitation Units: The SLPs’PerspectivePerspective

2. Patient-Provider Training to Communicate with2. Patient-Provider Training to Communicate withPeople who have Communication DisordersPeople who have Communication Disorders Contact: Contact: mamlekcr@mail.uc.edumamlekcr@mail.uc.edu

Language Recovery in Acute AphasicStroke PLORAS

• Predicting Language Outcomes and RecoveryAfter Stroke

• Group based at University College London• Compiling large database of MRIs and

behavioral data from people with aphasia andusing machine learning to develop and honeprediction algorithms

• Collaborators on this project

• Prospective, observational pilot study• Inclusion: adults with new aphasia due to

stroke• Exclusions:

• Premorbid aphasia, dementia, severe mentalillness

• Medically unstable• Unable to get MRI

• Primary endpoint: Comprehensive AphasiaTest (CAT) at 90 days

• Primary aims:Apply PLORAS imaging-based prediction

algorithm to acute stroke patientsImprove predictive power of original

Hope et al, NeuroImage: Clinical 2013

Final Enrollment Data• 32 patients enrolled

• 11 (34%) female• 9 (28%) African-American• Mean age 63 (range 40-85)

• 28 completed 3 month follow-up• 1 withdrew• 1 died• 2 lost to follow up Analysis in process…stay tuned!

On deck: Music Therapy for Aphasia• Hypothesis: Structured music therapy centered around singing can

improve speech production in people with chronic, non-fluent aphasia• Design: Single-arm, multiple baselines pilot study• Intervention: Novel MT protocol – Sing-to-Speak (S2S)

1) Sing familiar songs with and without therapist accompaniment2) Develop original, personalized lyrics to the tunes of the same familiar

songs; practice singing new lyrics with and without accompaniment3) Call-and-response, in which therapist sings a prompt and patient sings a

response4) Intonation: patient practices repeating and then initiating conversational

phrases intoned in a chant-like simple melody• Intensive regimen, 45 min 5 days/week x3 weeks• Outcome: Amsterdam-Nijmegen Everyday Language Test

Upcoming StrokeNetRecovery Trials

SLEEP-SMART• Phase 3, open label, blinded endpoint, RCT of 6 months of positive

airway pressure (PAP) vs. usual care• Combined recovery and prevention trial

EligibilityInclusion:• Age ≥18• Able to tolerate 1 night APAP• Prevention Aim:

• TIA with ABCD2 ≥4 or ischemic stroke within the prior 14 days• Recovery aim (subset)

• Ischemic stroke within the prior 7 days• NIH Stroke Scale Score ≥1

Exclusion:• Pre-event modified Rankin Scale Score ≥3• Unable to obtain informed consent from subject or surrogate

Auto-titrating PAP (APAP)• Treatment (SAFE!):

• Adjusts pressure (breath-by-breath based on a 5-breath average) based on:• Apneas• Flow limitations• Snoring

• Diagnostic information: • Pressure requirements• Residual apnea/hypopnea index• SDB: median pressure >5 or AHI ≥5

Trial Schema

• Trial of mCIMT + tDCS vs. sham for upper extremity motor recoveryafter stroke

• Dose-finding study • Local Pis: Wole Awosika & Kari Dunning

TRANSPORT-2

TRANSPORT-2• Aim 1:

• To determine an overall treatment effect among 3 dosing groups(sham+mCIMT, 2mA+mCIMT and 4mA+mCIMT) after the 2-weekintervention.

• Outcome measures: Fugl-Meyer Upper-Extremity scale immediately after2-week intervention, 1 month, and 3 months.

• Aim 2:

• To confirm safety (no significant differences in rate of adverse events),tolerability , and feasibility (>80% of subjects complete the treatmentprotocol and no unexplained/unresolved variability by site)

• Aim 3 (exploratory):• To investigate whether corticospinal tract integrity (CST tractography) , or

Trial Schema

EligibilityInclusion

• 21-80 years old• First-ever uni-hemispheric ischemic stroke that occurred at least 3 months ago• Unilateral limb weakness with Fugl-Meyer Upper Extremity score of ≤ 56 (out of 66)• At least 10 degrees of wrist dorsiflexion or 20 degrees of elbow flexion/extension• An absolute difference of FM-UE scores between two baseline assessments that is ≤ 4 points indicating

patient has a stable motor impairmentExclusion

• Taking prohibited drugs: carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan• Other co-existent neuromuscular disorders affecting upper extremity motor function• Other neurological disorders(eg. severe dementia or parkinson disease) pre- or post-stroke affecting

subject’s ability to pariticipate in the study• History of medically uncontrolled depression or other psychiatric disorder despite medications either

before or after stroke that may subject’s ability to participate in the study• Uncontrolled hypertension despite medical treatment(s) at the time of enrollment, defined as

SBP≥185mmHg or DBP≥110mmHg• Metal implants• Pregnancy

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iACQUIRE• Initial RCT design: 240 infants (8 to 24 mos old) randomly

assigned to one of 3 groups:•Moderate intensity ACQUIRE (N=80)•High intensity ACQUIRE (N=80)•Usual & Customary treatment (UCT) with careful

documentation (N=80)•Crossover (delayed treatment): The 80 infants (14 to 30 mos

old) in the initial UCT group will be randomly assigned toModerate or High Intensity ACQUIRE after 6 mos follow-up, ifearly evidence of efficacy obtained•Blinded assessments at baseline, 1 month post-treatment, 6

months post-treatment, and at 36 months old (common age

Aims•Aim 1: Test efficacy of 2 dosages of Infant ACQUIRE therapy

compared to usual care (UCT) for immediate and 6 mosoutcomes• H1: Both dosages of Infant ACQUIRE > UCT• H2: High dosage outcomes > moderate dosage, with increasing

difference at 6 months vs immediate post-tx•Aim 2: to assess effects of age when treated by conducting

delayed treatment/crossover trial of infants in UCT group*• H3: Regardless of age, Infant ACQUIRE will produce clinically

significant effects (>25% improvement compared to baseline)• H4: In general, infants treated at earlier ages will show larger effect

sizes (i.e., be higher functioning) - particularly at 36 mos of age -compared to those treated at later ages

* ethical considerations also important for UCT patients in crossover/delayed treatment group31

Primary and Secondary Outcomes•Primary: skillful use of upper extremity (adjusting for age), trunk

control, and mobility [all sessions videotaped/scored blind]• Emerging Behaviors Scale (EBS)• Mini-AHA (Assisting Hand Assessment)• Bayley Scales of Infant Development III – Fine and Gross Motor

subscales, with research scoring protocol for hemiparesis•Secondary: language and cognitive development, social-

emotional development, and levels of engagement (ratings ofdaily use of upper extremity in typical activities)• Bayley Scales of Infant Development III subscales• Infant Motor Activity Log (IMAL) (parent report, therapist report)

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Healthy Goal Achievement through Action Planning andLifestyle Management after Stroke Study (Healthy GOALS)• Funding: NIH-NIMHD• PI: Valerie Hill• Design: RCT with delayed control • Specific Aims:• To test the efficacy of the Healthy GOALS community-based, life

management intervention to improve: (a) stroke-specific quality of lifeand meaningful activity engagement; (b) healthy behaviors; (c)health-related biomarkers in 58 ethnically/racially diverseunderrepresented stroke survivors from disadvantaged backgrounds.

• To conduct a cost analysis of re-hospitalizations, and inpatient andoutpatient services rendered comparing participants from the HealthyGOALS and control groups.

Healthy GOALSStudy Flow Diagram

Healthy GOALSConceptual Model

Caregiver Self-Management Needs Through Skill-Building (R21NR016992) ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03635151?term=Tamilyn+Bakas&rank=1 ; TASK III Website: https://www.task3web.com/

PI: Tamilyn Bakas, PhD, RN, FAHA, FAAN Co-Is: Bonnie Brehm, Kari Dunning, Brett Kissella, Michael McCarthy, Elaine Miller, Matt Rota,Heidi Sucharew, Determine feasibility of the Telephone Assessment and Skill-Building Kit (TASK

III) in 74 family caregivers of stroke survivors randomized to TASK III or to anInformation, Support, and Referral (ISR) group:

a) Measuring recruitment, retention, and treatment fidelity ratings for TASK III and ISRgroups;

b) Obtaining satisfaction and technology ratings (usability, ease of use, acceptability) forTASK III and ISR groups;

c) Comparing outcome measures (depressive symptoms, other symptoms [fatigue, pain,shortness of breath, stress, sleep], life changes, unhealthy days, SM of diet/exercise,self-reported healthcare utilization) and potential mediators (task difficulty, threat

Visit ourTASK III Website:

https://www.task3web.com/

Tamilyn Bakas, PhD,RNUniversity of CincinnatiCollege of Nursing513-558-2254Tamilyn.bakas@uc.edu

Thank you!Tamilyn Bakas, PhD, RN, FAHA,

FAANProfessor

Jane E. Procter Endowed ChairUniversity of Cincinnati

College of Nursing513-558-2254

Tamilyn.Bakas@uc.edu