StrokePASSNCT03861806
Reliability of Paired Associative Stimulation-induced Neuroplasticity After Stroke
A study testing PAS true in people with Stroke, run by Burke Medical Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- PAS true
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 12 Sep 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Neurological Institute
White Plains, New York, 10605
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- PAS true, PAS sham
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAS trueBehavioural
Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability.
PAS shamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PAS true | Experimental | Participants will receive paired associative stimulation therapy with a modulatory inter-stimulus interval. Receives: Behavioral: PAS true |
| PAS sham | Sham comparator | Participants will receive paired associative stimulation therapy with a non modulatory inter-stimulus interval. Receives: Behavioral: PAS sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor evoked potential amplitude
Assessment of corticospinal excitability
Measured: Baseline, up to 30 min Post PAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start17 Apr 2019
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We plan a randomized crossover study of sham and true PAS.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomoko Kitago, Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861806
- Sponsor's protocol ID
- HMRL-001
- Acronym
- PASS
- Status last verified
- Nov 2022
- First submitted
- 26 Feb 2019
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Paired Associative Stimulation-induced Neuroplasticity After Stroke
- ClinicalTrials.gov ID
- NCT03861806
- Acronym / sponsor ID
- PASS / HMRL-001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 4 Mar 2019 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We plan a randomized crossover study of sham and true PAS.
| Arm | Type | Receives |
|---|---|---|
| PAS true | Experimental | Behavioral: PAS trueParticipants will receive paired associative stimulation therapy with a modulatory inter-stimulus interval. |
| PAS sham | Sham comparator | Behavioral: PAS shamParticipants will receive paired associative stimulation therapy with a non modulatory inter-stimulus interval. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PAS trueParticipants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability. | Behavioural | PAS true |
| PAS shamParticipants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to not modulate corticospinal excitability. | Behavioural | PAS sham |
Primary outcome
Change in motor evoked potential amplitude
Time frame: Baseline, up to 30 min Post PAS
Assessment of corticospinal excitability
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
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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 PAS true in people with Stroke, run by Burke Medical Research Institute 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Nov 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 was stopped early (reason given: lack of funding). Results are not available in the source record.
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?
Change in motor evoked potential amplitude (time frame: Baseline, up to 30 min Post PAS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2022.