StrokeNCT02586597
Paired Associative Stimulation in Stroke
A study testing Transcranial magnetic stimulation & median nerve stimulation in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial magnetic stimulation & median nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years old;
- first-ever ischemic stroke involving only one hemisphere;
- Patient demonstrates at least 10 degrees of voluntary finger, thumb and wrist extension; ;
- 6 - 24 months after ischemic stroke
Who cannot join
- 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;
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Paired Associative Stimulation Modulates Motor Excitability and Plasticity in Chronic Stroke Patients
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Transcranial magnetic stimulation & median nerve stimulation
- Keywords
- Stroke, PAS, TMS, cortical excitability, plasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation & median nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PAS 10: TMS and median nerve stimulation | Experimental | 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. Receives: Device: Transcranial magnetic stimulation & median nerve stimulation |
| PAS 25:TMS and median nerve stimulation | Experimental | 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. Receives: Device: Transcranial magnetic stimulation & median nerve stimulation |
| PAS100:TMS and median nerve stimulation | Sham comparator | 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. Receives: Device: Transcranial magnetic stimulation & median nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracortical facilitation
the peak magnitude of MEP
Measured: 10-day treatment
Secondary outcomes (3)
Clinical behavioral measures-Handgrip
hand grip strength
Measured: 10-day treatment
Nine-hole peg test
screening tool to administer Portable assess finger dexterity and median nerve function
Measured: 10-day treatment
wolf motor function test
To measure upper extremity motor ability through timed and functional tasks
Measured: 10-day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start1 Feb 2015
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingbao Li, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586597
- Sponsor's protocol ID
- Pro00040369
- Status last verified
- Feb 2022
- First submitted
- 17 Mar 2015
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19238517
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Associative Stimulation Modulates Motor Excitability and Plasticity in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT02586597
- Acronym / sponsor ID
- Pro00040369
- Conditions
- Stroke
- Keywords
- Stroke, PAS, TMS, cortical excitability, plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAS 10: TMS and median nerve stimulation | Experimental | Device: Transcranial magnetic stimulation & median nerve stimulationPaired 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 | Experimental | Device: Transcranial magnetic stimulation & median nerve stimulationPAS 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 comparator | Device: Transcranial magnetic stimulation & median nerve stimulationPAS 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years old;
- first-ever ischemic stroke involving only one hemisphere;
- Patient demonstrates at least 10 degrees of voluntary finger, thumb and wrist extension; ;
- 6 - 24 months after ischemic stroke
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation & median nerve stimulationPaired 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. | Device | PAS 10: TMS and median nerve stimulation, PAS 25:TMS and median nerve stimulation, PAS100:TMS and median nerve stimulation |
Primary outcome
Intracortical facilitation
Time frame: 10-day treatment
the peak magnitude of MEP
3 secondary outcomes
Clinical behavioral measures-Handgrip
Time frame: 10-day treatment
Nine-hole peg test
Time frame: 10-day treatment
wolf motor function test
Time frame: 10-day treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 19238517Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation & median nerve stimulation in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracortical facilitation (time frame: 10-day treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.