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Reliability of Paired Associative Stimulation-induced Neuroplasticity After Stroke (PASS)

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ClinicalTrials.gov Identifier: NCT03861806
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tomoko Kitago, Burke Medical Research Institute

Brief Summary:
Paired associative stimulation (PAS) is a non-invasive stimulation method which is known to modulate corticospinal excitability through mechanisms related to long-term potentiation and long-term depression. The purpose of this study is to determine the reliability of individual subject's response (i.e., change in corticospinal excitability) to PAS in patients with chronic stroke (>6 months) with upper limb motor deficits.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: PAS true Behavioral: PAS sham Not Applicable

Detailed Description:

One of the assumptions in stroke rehabilitation is that motor training will lead to motor re-learning and persistent improvements through mechanisms involving neuroplasticity, defined as the ability of the brain to change its structure and function in response to injury, activity, or change in environment. A way to measure a patient's capacity for neuroplasticity may be useful in guiding selection of patients for rehabilitative interventions, or to assess the effect of pharmacological agents on neuroplasticity which may aid in augmenting motor recovery. One method to assess neuroplasticity non-invasively in humans through the use of paired associative stimulation (PAS). PAS is a form of non-invasive stimulation that modulates corticospinal excitability through mechanisms related to long-term potentiation (LTP) and long-term depression (LTD). In PAS, repetitive pairing of peripheral nerve stimulation with a transcranial magnetic stimulation (TMS) pulse over the contralateral motor cortex will increase or decrease corticospinal excitability, depending on the timing between the two stimuli. In healthy subjects and patients with stroke, PAS has successfully been used to facilitate corticospinal excitability as a means to enhance motor performance. In this study, we plan to use PAS as an assay of corticospinal plasticity rather than as a therapeutic intervention in patients with chronic motor deficits (>6 months) due to ischemic stroke.

There is large interindividual variability in individuals' responses to PAS, which may be useful in examining its relationship to motor learning, but the reliability of the measure will need to be assessed prior to using this measure to make inferences about a subject's general capacity to learn motor tasks. The reliability of the response to PAS and its relationship to clinical factors such as stroke severity, has not been well studied in patients with stroke. Results from a preliminary experiment suggest that stroke patients who have a robust response to facilitatory PAS on their unaffected hemisphere have more severe motor deficits than those who do not have a significant response to PAS.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We plan a randomized crossover study of sham and true PAS.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reliability of Paired Associative Stimulation-induced Neuroplasticity After Stroke
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: PAS true
Participants will receive paired associative stimulation therapy with a modulatory inter-stimulus interval.
Behavioral: PAS true
Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability.

Sham Comparator: PAS sham
Participants will receive paired associative stimulation therapy with a non modulatory inter-stimulus interval.
Behavioral: PAS sham
Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to not modulate corticospinal excitability.




Primary Outcome Measures :
  1. Change in motor evoked potential amplitude [ Time Frame: Baseline, up to 30 min Post PAS ]
    Assessment of corticospinal excitability



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral ischemic stroke with residual arm weakness (Fugl-Meyer Upper Limb < 60) more than 6 months prior to enrollment.
  • Ability to give informed consent and understand the tasks involved.
  • Age over 18 years.

Exclusion Criteria:

  • Hemorrhagic Stroke
  • Contraindications to TMS: history of seizure/epilepsy, pacemaker, other neurological disorders, brain surgery, metal implant/fragment in the head, pregnancy
  • Taking medications or substances that are known to affect PAS-induced plasticity within the past 2 months: selective serotonin reuptake inhibitors, dopamine, dopamine agonists, haloperidol, lithium, acetylcholinesterase inhibitors, beta-blockers, nimodipine, levetiracetam, ethosuximide, benzodiazepines, baclofen, nicotine
  • Peripheral neuropathy or history of nerve injury in the paretic upper limb.
  • Social and/or personal circumstances that interfere with ability to return for all study visits.

Information from the National Library of Medicine

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): NCT03861806


Contacts
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Contact: Tomoko Kitago, M.D. 914-368-3169 ext +1 tok7002@med.cornell.edu
Contact: Stuart W Mackenzie, PhD. 914-368-3179 ext +1 stm4004@med.cornell.edu

Locations
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United States, New York
Burke Neurological Institute Recruiting
White Plains, New York, United States, 10605
Contact: Tomoko Kitago, M.D    914-368-3169 ext +1    tok7002@med.cornell.edu   
Contact: Stuart W Mackenzie, PhD.    914-368-3179 ext +1    stm4004@med.cornell.edu   
Sponsors and Collaborators
Burke Medical Research Institute

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Responsible Party: Tomoko Kitago, Lab Director, Burke Medical Research Institute
ClinicalTrials.gov Identifier: NCT03861806     History of Changes
Other Study ID Numbers: HMRL-001
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases