Study Stopped
The study was suspended in 2020 due to COVID-19 safety measures. Follow up with those previously enrolled later resumed, but not all subjects returned due to the ongoing pandemic. The study closed after attempting to obtain as much data as possible.
Customized Cortical Stimulation Therapy in the Rehabilitation of Stroke Patients
2 other identifiers
interventional
100
1 country
3
Brief Summary
The purpose of this study is to identify and establish how the area of the brain that controls motor function (motor cortex) of the non-affected hemisphere after stroke might serve as a new target for therapeutic interventions to improve motor performance after stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 2015
Longer than P75 for not_applicable stroke
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2021
CompletedResults Posted
Study results publicly available
August 23, 2022
CompletedAugust 31, 2023
August 1, 2023
5.3 years
September 7, 2015
March 9, 2022
August 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Motor Function Assessed by the Jebsen Test
The Jebsen Test assesses weighted and non-weighted hand function among participants who have had a stroke. Subjects are assessed through writing, turning over 3 by 5 inch cards, picking up small common objects, simulated feeding, stacking checkers, picking up large objects, and picking up large heavy objects. Patients are required to perform all of the subtests with both the right and left hands. Time to complete each task is recorded and normalized to healthy age and sex matched control subjects. The score ranges from 0 to 1 with 0 being normal.
1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)
Mean Motor Evoked Potential (MEP) Amplitudes Assessed by Stimulus Response Curve (SRC) of the Contralesional M1
Change in mean motor evoked potential (MEP) amplitudes at each stimulus intensity will be calculated. The sum of these means is calculated as the area under the curve.
1 month post-stroke (subacute stroke) or single study visit for healthy controls, 6 months post-stroke (chronic stroke)
Presence of MEP in Response to TMS of the Ipsilesional M1
The presence of motor evoked potential (MEP) in response to maximum TMS applied to ipsilesional M1 was determined in participants with stroke.
1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)
Lesion Volume
Normalized stroke lesion volume was determined at the one-month time point using structural MRI of the brain.
1 month post-stroke (subacute stroke)
Corticospinal Tract (CST) Lesion
Corticospinal tract (CST) lesion load will be determined at the one-month time point using structural MRI of the brain. The lesion size is expressed as percentage of the entire CST.
1 month post-stroke (subacute stroke)
Secondary Outcomes (7)
Motor Function Assessed by Time to Complete the Wolf Motor Function Test (WMFT)
1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)
Motor Function Assessed by Grip Strength During the Wolf Motor Function Test (WMFT)
1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)
Use of Paretic Arm Assessed by the Motor Activity Log (MAL)
1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)
CST Subpathway Originating in M1 Lesion Load
1 month post-stroke (subacute stroke)
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
1 month post-stroke (subacute stroke) or single study visit for healthy controls, 6 months post-stroke (chronic stroke)
- +2 more secondary outcomes
Study Arms (2)
Stroke Patients
EXPERIMENTALSubjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
Healthy Controls
ACTIVE COMPARATORSubjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months.
Interventions
Single-pulse Transcranial Magnetic Stimulation (TMS) is a brief magnetic pulse that is applied through a coil to the section of the head that overlays the motor cortex of the brain. Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Single-pulse transcranial magnetic stimulation (TMS) will be administered at study visits.
Paired-pulse Transcranial Magnetic Stimulation (ppTMS) is two brief sequential magnetic pulses that are applied through a coil to the section of the head that overlays the motor cortex of the brain. Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Paired-pulse transcranial magnetic stimulation (ppTMS) will be administered at study visits.
Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) is a sequence of brief magnetic pulses that are applied at 0.1 Hz frequency at low intensity through an air-cooled coil to the section of the head that overlays the motor cortex of the brain. Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Low-frequency repetitive transcranial magnetic stimulation (rTMS) will be administered at study visits.
Sham motor cortex stimulation will be applied at study visits.
Eligibility Criteria
You may qualify if:
- The ability to provide informed consent
- Ages 40 to 80 years old
- Male or female
- One cerebral ischemic infarction less than 1 month affecting the primary motor output system of the hand at a cortical (M1) level as defined by magnetic resonance imaging (MRI) of the brain
- Paresis of the hand for more than 3 days after their cerebral infarction
- Normal MRI of the brain
- Normal neuropsychological testing
- Normal neurological examination
You may not qualify if:
- Neurological disorders other than stroke
- Aphasia that prevents following instructions or inability to communicate effectively with the study team
- Dementia
- Moderate or severe depression
- Contraindication to transcranial magnetic stimulation (TMS) and/or MRI
- Use of central nervous system (CNS) active drugs that block plasticity
- Neurological Disease
- Psychiatric Disease
- Use of CNS active drugs
- Contraindication to transcranial magnetic stimulation (TMS) and/or MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Center for Rehabilitation Medicine
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Related Publications (3)
Revill KP, Rizor E, Haut MW, Grafton ST, Buetefisch CM. Mean Motor Disconnectivity Predicts Hand Function Impairment After Stroke: Beyond Motor Cortex Output. Stroke. 2026 Jan 7. doi: 10.1161/STROKEAHA.125.052559. Online ahead of print.
PMID: 41498148DERIVEDWischnewski M, Edwards L, Revill KP, Drake D, Hobbs G, Buetefisch CM. Intensity-Dependent Effects of Low-Frequency Subthreshold rTMS on Primary Motor Cortex Excitability and Interhemispheric Inhibition in Elderly Participants: A Randomized Trial. Neurorehabil Neural Repair. 2025 Jan;39(1):58-73. doi: 10.1177/15459683241292615. Epub 2024 Oct 27.
PMID: 39462433DERIVEDBuetefisch CM, Haut MW, Revill KP, Shaeffer S, Edwards L, Barany DA, Belagaje SR, Nahab F, Shenvi N, Easley K. Stroke Lesion Volume and Injury to Motor Cortex Output Determines Extent of Contralesional Motor Cortex Reorganization. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):119-130. doi: 10.1177/15459683231152816. Epub 2023 Feb 14.
PMID: 36786394DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cathrin Buetefisch, MD, PhD
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Cathrin Buetefisch, MD, PhD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 7, 2015
First Posted
September 9, 2015
Study Start
November 5, 2015
Primary Completion
February 4, 2021
Study Completion
February 4, 2021
Last Updated
August 31, 2023
Results First Posted
August 23, 2022
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share