Novel Brain Stimulation Therapies in Stroke Guided Expressions of Plasticity
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|ClinicalTrials.gov Identifier: NCT03020433|
Recruitment Status : Unknown
Verified January 2017 by Ela B Plow, PhD, PT, The Cleveland Clinic.
Recruitment status was: Recruiting
First Posted : January 13, 2017
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke Cerebrovascular Disorders Nervous System Diseases Brain Diseases Cardiovascular Diseases Vascular Diseases Central Nervous System Diseases||Device: rTMS Contralesional M1 Device: rTMS Contralesional PMC Device: rTMS Ipsilesional PMC Device: rTMS sham at Ipsilesional M1||Early Phase 1|
AIMS: The ultimate goal is to personalize brain stimulation for stroke so outcomes of the upper limb can be maximized for each individual patient. Even though stimulation is one of the most well studied methods to augment plasticity and boost recovery, it is still not approved for outpatient therapy. Benefits of stimulation are weak and variable especially in patients who suffer from greater damage and disability. The key limitation of the standard approach is its generic assumptions about plasticity. The current standard assumes that ipsilesional primary motor cortex (iM1) can impact recovery for patients in all ranges of severity, and intact, contralesional cortices always compete with iM1 to inhibit recovery. But, these long-standing assumptions fail to consider that iM1 or its pathways are damaged in a majority (58-83%) of patients. As such, the potential of iM1 would be weak and variable, and patients will have little option but to rely on plasticity of intact, contralesional cortices that are more likely to survive. Of all surviving cortices, contralesional dorsal premotor cortex (cPMd) expresses plasticity most consistently. cPMd is activated in movement of the paretic limb when activating iM1 is less likely. cPMd even reduces its competition with iM1 and offers its ipsilateral pathways instead to support recovery of the proximal paretic limb when pathways from iM1 are largely damaged.
Several groups including the investigator have recently theorized that personalizing stimulation so as to selectively stimulate iM1 in mild, and cPMd in patients with greater severity would help generalize benefits of stimulation. These theoretical claims, however, remain untested since several gaps exist. For instance, what is the cut-off level of severity that stratifies those who respond to stimulation of iM1 from those who respond to stimulation of cPMd? Even then, are substrates for 'personalized' stimulation same as the substrates that express plasticity in recovery, i.e. if patients benefit from stimulation of cPMd, do they express contralesional plasticity in recovery? Here, the investigator premise that variances in expressions of plasticity can explain how to best stratify patients for robust, personalized stimulation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Novel Brain Stimulation Therapies in Stroke Guided Expressions of Plasticity|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
|Active Comparator: rTMS Contralesional M1 Inhibition||
Device: rTMS Contralesional M1
1Hz Contalesional M1 repetitive transcranial magnetic stimulation (1500 pulses, 25 minutes, 90% AMT
|Active Comparator: rTMS Contralesional PMC facilitation||
Device: rTMS Contralesional PMC
5Hz Contralesional PMC repetitive transcranial magnetic stimulation (1500 pulses, 10 minutes, 5 trains of 300 pulses each with 1 minute rest in between, 90% AMT)
|Active Comparator: rTMS Ipsilesional PMC facilitation||
Device: rTMS Ipsilesional PMC
5HZ Ipsilesional PMC repetitive transcranial magnetic stimulation (1500 pulses, 10 minutes, 5 trains of 300 pulses each with 1 minute rest in between, 90% AMT)
|Sham Comparator: rTMS Sham at Ipsilesional M1||
Device: rTMS sham at Ipsilesional M1
1Hz Ipsilesional M1 sham repetitive transcranial magnetic stimulation (1500 pulses, 25 minutes, 50% MSO)
- Aim 1: Change in time (seconds) to perform functional reaching [ Time Frame: Change in functional reaching from baseline to post rTMS, assessed for approximately 4-6 hours. ]Patients will be seated with test arm resting on a table. Three buttons (labeled 1, 2, 3) will be arranged in a semi-circle at 80% of reaching distance of the paretic limb. A number (1, 2, or 3) will cue patients to reach and push the designated button as fast as possible using shoulder flexion-abduction and elbow extension while their trunk is stabilized. Three blocks of 20 trials will be tested pre- and post-rTMS.
- Aim 2:Change in plasticity evoked with rTMS. [ Time Frame: Change in neurophysiology from baseline to post rTMS assessed for approximately 4-6 hours. ]Expressions of plasticity will be noted for ipsilesional vs. contralesional pathways and inhibition imposed on ipsilesional cortices from contralesional cortices. Subjects will be stratified based on which stimulation location evoked the most plasticity from each of the arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020433
|Contact: Ela Plow, PhD, PTfirstname.lastname@example.org|
|Contact: Kyle O'Laughlin, MSemail@example.com|
|United States, Ohio|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Ela Plow, PhD, PT 216-445-4589 firstname.lastname@example.org|
|Contact: Kyle O'Laughlin, MS 216-445-6728 email@example.com|
|Principal Investigator:||Ela Plow, PhD||The Cleveland Clinic|