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Trial record 9 of 44 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

Paired Associative Stimulation in Stroke

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ClinicalTrials.gov Identifier: NCT02586597
Recruitment Status : Recruiting
First Posted : October 26, 2015
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Xingbao Li, Medical University of South Carolina

Brief Summary:
Stroke is the third most common cause of death in the United States after heart disease and cancer, and the leading cause of long-term disability. This work will develop an innovative brain stimulation method (paired associative stimulation) which might set the stage for a new treatment for stroke rehabilitation.

Condition or disease Intervention/treatment Phase
Stroke Device: Transcranial magnetic stimulation & median nerve stimulation Not Applicable

Detailed Description:

Stroke is the third most common cause of death in the United States after heart disease and cancer. An innovative recovery treatment is in demand for stroke motor recovery. Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS motor-evoked potentials (MEP's). The investigators will also compare post-stroke patients to healthy controls on the modulation effect of PAS and motor behavior measures.

Aim1. To investigate whether PAS (PAS25 or PAS10) can modulate motor excitability and plasticity;

Aim2. To investigate whether PAS can modify motor behaviors measures in both post-stroke patients and healthy controls;

Aim3. To investigate whether post-stroke patients show different modulation of PAS on both cortical plasticity and motor behavior measure compared to healthy controls.

For this study the investigators will enroll a total of 10 chronic stroke patients and 10 neurologically healthy controls matched for age and gender. Participants will have 4 visits. The first visit is for screening. They will receive either sham PAS or real PAS25 or real PAS10 at each following treatment visit.

Experimental Methods: Clinical Behavioral Measures: Handgrip; Nine-hole Peg Test; Wolf Motor Function Test; Imaging protocol: T1 weighted anatomical image, fluid attenuation inversion recovery (FLAIR) and diffusion tensor imaging (DTI); Stimulation locations: Left primary motor (M1); right median nerve; PAS methods: TMS stimulation will be delivered at 25 ms or 10 ms or 100 ms after median nerve stimulation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paired Associative Stimulation Modulates Motor Excitability and Plasticity in Chronic Stroke Patients
Study Start Date : February 1, 2015
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Arm Intervention/treatment
Experimental: PAS 10: TMS and median nerve stimulation
Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation. The interval between median nerve stimulation and TMS was chosen to be 10 ms, which is called PAS10. PAS 10: TMS and median nerve stimulation: 240 paired median nerve stimulation and TMS during 20 minutes.
Device: Transcranial magnetic stimulation & median nerve stimulation

Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation.

PA25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. 240 paired TMS and median nerve stimulation at a frequency of 0.2 Hz over 20 min.

PAS10: 240 paired TMS and median nerve stimulation with interval of 10 min second at a frequency of 0.2 Hz over 20 min.

PAS100: 240 paired TMS and median nerve stimulation with interval of 100 min second at a frequency of 0.2 Hz over 20 min.


Experimental: PAS 25:TMS and median nerve stimulation
PAS 25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. PAS 25:TMS and median nerve stimulation: 240 paired median nerve stimulation and TMS during 20 minutes.
Device: Transcranial magnetic stimulation & median nerve stimulation

Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation.

PA25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. 240 paired TMS and median nerve stimulation at a frequency of 0.2 Hz over 20 min.

PAS10: 240 paired TMS and median nerve stimulation with interval of 10 min second at a frequency of 0.2 Hz over 20 min.

PAS100: 240 paired TMS and median nerve stimulation with interval of 100 min second at a frequency of 0.2 Hz over 20 min.


Sham Comparator: PAS100:TMS and median nerve stimulation
PAS Control Paradigm: The interval between median nerve stimulation and TMS was chosen to be 100 ms, which is called PAS100. PAS100:TMS and median nerve stimulation: 240 paired median nerve stimulation and TMS during 20 minutes.
Device: Transcranial magnetic stimulation & median nerve stimulation

Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation.

PA25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. 240 paired TMS and median nerve stimulation at a frequency of 0.2 Hz over 20 min.

PAS10: 240 paired TMS and median nerve stimulation with interval of 10 min second at a frequency of 0.2 Hz over 20 min.

PAS100: 240 paired TMS and median nerve stimulation with interval of 100 min second at a frequency of 0.2 Hz over 20 min.





Primary Outcome Measures :
  1. Intracortical facilitation [ Time Frame: 10-day treatment ]
    the peak magnitude of MEP


Secondary Outcome Measures :
  1. Clinical behavioral measures-Handgrip [ Time Frame: 10-day treatment ]
    hand grip strength

  2. Nine-hole peg test [ Time Frame: 10-day treatment ]
    screening tool to administer Portable assess finger dexterity and median nerve function

  3. wolf motor function test [ Time Frame: 10-day treatment ]
    To measure upper extremity motor ability through timed and functional tasks



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18-80 years old;
  2. first-ever ischemic stroke involving only one hemisphere;
  3. Patient demonstrates at least 10 degrees of voluntary finger, thumb and wrist extension; ;
  4. 6 - 24 months after ischemic stroke

Exclusion Criteria:

  1. Primary or secondary intracerebral hematoma, or subarachnoid hemorrhage, or subdural/epidural hematoma;
  2. Bihemispheric ischemic strokes;
  3. History of prior stroke or old infarct demonstrated on the CT or MRI or documented in medical records or current on anticoagulant;
  4. Other concomitant neurological disorders, such as brain tumor, abscess or spinal cord disease affecting upper extremity motor function;
  5. Documented history of dementia prior to index event;
  6. Presence of any MRI/TMS risk factors such as (a) an electrically, magnetically or mechanically activated implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; (b) non-fixed metal in any part of the body, including a previous metallic injury to eye [all jewelry will be removed during stimulation]; (c) pregnancy, since the effect of TMS on the fetus is unknown, females of child bearing age will have to undergo a pregnancy test to confirm eligibility; (d) history of seizure disorder or post-stroke seizures. This last exclusion criterion applies only to the modulation portion of the proposal; (e) median nerve is damaged

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): NCT02586597


Contacts
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Contact: Scott J Henderson, BA 843-792-5560
Contact: Xingbao Li, MD 843-792-5729

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Xingbao Li, M.D    843-792-5729    lixi@musc.edu   
Principal Investigator: Xingbao Li, M.D         
Sponsors and Collaborators
Medical University of South Carolina

Publications:
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Responsible Party: Xingbao Li, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02586597     History of Changes
Other Study ID Numbers: Pro00040369
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Keywords provided by Xingbao Li, Medical University of South Carolina:
Stroke
PAS
TMS
cortical excitability
plasticity
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases