Paired Associative Stimulation in Stroke
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Feb 2015
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2021
CompletedApril 28, 2022
February 1, 2022
6.8 years
March 17, 2015
April 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intracortical facilitation
the peak magnitude of MEP
10-day treatment
Secondary Outcomes (3)
Clinical behavioral measures-Handgrip
10-day treatment
Nine-hole peg test
10-day treatment
wolf motor function test
10-day treatment
Study Arms (3)
PAS 10: TMS and median nerve stimulation
EXPERIMENTALPaired 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.
PAS 25:TMS and median nerve stimulation
EXPERIMENTALPAS 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.
PAS100:TMS and median nerve stimulation
SHAM COMPARATORPAS 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old;
- first-ever ischemic stroke involving only one hemisphere;
- Patient demonstrates at least 10 degrees of voluntary finger, thumb and wrist extension; ;
- months after ischemic stroke
You may not qualify if:
- Primary or secondary intracerebral hematoma, or subarachnoid hemorrhage, or subdural/epidural hematoma;
- Bihemispheric ischemic strokes;
- History of prior stroke or old infarct demonstrated on the CT or MRI or documented in medical records or current on anticoagulant;
- Other concomitant neurological disorders, such as brain tumor, abscess or spinal cord disease affecting upper extremity motor function;
- Documented history of dementia prior to index event;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (1)
Li X, Ricci R, Large CH, Anderson B, Nahas Z, George MS. Lamotrigine and valproic acid have different effects on motorcortical neuronal excitability. J Neural Transm (Vienna). 2009 Apr;116(4):423-9. doi: 10.1007/s00702-009-0195-z. Epub 2009 Feb 24.
PMID: 19238517BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 17, 2015
First Posted
October 26, 2015
Study Start
February 1, 2015
Primary Completion
November 2, 2021
Study Completion
November 2, 2021
Last Updated
April 28, 2022
Record last verified: 2022-02