Stroke, IschemicPhase 1/2NCT04221256
Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity
A Phase 1/2 study testing Administration of SSRI escitalopram and Paired Associative stimulation in people with Stroke, Ischemic, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
The brain is able to change throughout life in response to learning, or injury, or to adapt to changes in the environment, which is known as neuroplasticity. Stroke survivors suffer disabling chronic motor impairments that have proven challenging to improve. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Administration of SSRI escitalopram and Paired Associative stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 9 Feb 2021
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker
- Current or history of neurological disorders or brain lesions such as stroke, multiple sclerosis, tumor, traumatic brain injury, spinal cord injury
- Diagnosis of major depressive disorder or other psychiatric disorder
- Currently taking escitalopram or another selective serotonin reuptake inhibitor
- Currently taking or have taken in the past month other medications or supplements that have known interactions with escitalopram or can precipitate serotonin syndrome when taken in combination with escitalopram: monoamine oxidase inhibitors, methylene blue, linezolid, serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants (TCAs), fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort
- Known hypersensitivity to escitalopram or any of its inactive ingredients.
Show all 24Show fewer
- History of cerebral hemorrhage, gastrointestinal bleeding, or genitourinary bleeding.
- History of prolonged QTc
- Pregnant or breastfeeding
- Social and/or personal circumstances that interfere with the ability to return for all study visits.
- Stroke Patients Inclusion criteria
- Men and women aged 18 years and older.
- Ability to give informed consent.
- History of ischemic stroke
- Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker
- Current or history of neurological disorders or brain lesions such as multiple sclerosis, tumor, traumatic brain injury, spinal cord injury
- Diagnosis of major depressive disorder or other psychiatric disorder
- Currently taking escitalopram or another selective serotonin reuptake inhibitor
- Currently taking or have taken in the past month other medications or supplements that have known interactions with escitalopram or can precipitate serotonin syndrome when taken in combination with escitalopram: monoamine oxidase inhibitors, methylene blue, linezolid, serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants (TCAs), fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort
- Known hypersensitivity to escitalopram or any of its inactive ingredients.
- History of cerebral hemorrhage, gastrointestinal bleeding, or genitourinary bleeding.
- History of prolonged QTc
- Pregnant or breastfeeding
- Social and/or personal circumstances that interfere with the 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
The brain is able to change throughout life in response to learning, or injury, or to adapt to changes in the environment, which is known as neuroplasticity. Stroke survivors suffer disabling chronic motor impairments that have proven challenging to improve. Increasing neuroplasticity using selective serotonin reuptake inhibitors (SSRIs) is a promising approach to promote motor recovery in patients with stroke.
Read the detailed description
The brain is able to change throughout life in response to learning, or injury, or to adapt to changes in the environment, which is known as neuroplasticity. Stroke survivors suffer disabling chronic motor impairments that have proven challenging to improve. Increasing neuroplasticity using selective serotonin reuptake inhibitors (SSRIs) is a promising approach to promote motor recovery in patients with stroke. Selective serotonin reuptake inhibitors (SSRIs) are currently widely used for treatment of depression, but they also have been shown to be able to enhance neuroplasticity. A single dose of SSRI has been shown to improve hand function in patients with chronic stroke. SSRIs also enhance neuroplasticity in healthy individuals, as shown using paired associative stimulation (PAS), a non-invasive method which causes the brain's excitability to change. However, the best dose of SSRI to increase neuroplasticity is not yet established.
The purpose of this study is to (1) find the effective dose of the SSRI escitalopram to modulate PAS-induced plasticity in patients with stroke and healthy individuals and (2) determine the variability of escitalopram's effect on PAS-induced plasticity between individuals. We measure neuroplasticity with PAS, which causes the brain's excitability to change. During PAS, you would receive electrical stimulation over your wrist and magnetic stimulation to their scalp (called transcranial magnetic stimulation, or TMS) to increase the excitability of the motor area of the brain. You will be asked to participate in a screening visit and 8 study visits separated by at least 1 week. At each study visit, you will be given a single dose of escitalopram (5, 10 or 20) or placebo, and we will measure your brain's change in excitability after PAS.
- Conditions
- Stroke, Ischemic
- Being tested
- Administration of SSRI escitalopram, Paired Associative stimulation, Administration of Placebo
- Keywords
- Selective Serotonin Reuptake Inhibitor, Neuroplasticity, Paired Associative Stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of SSRI escitalopramDrug
Participants will be administered 5, 10 or 20mg of SRRI escitalopram prior to paired associative stimulation
Paired Associative stimulationBehavioural
Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability.
Administration of PlaceboDrug
Participants will be administered a placebo prior to paired associative stimulation
| Study group | Role | What they receive |
|---|---|---|
| Administration of SSRI | Experimental | Participants will be administered either 5, 10 or 20mg of SSRI escitalopram prior to paired associative stimulation. Receives: Drug: Administration of SSRI escitalopram; Behavioral: Paired Associative stimulation |
| Administration of Placebo | Placebo comparator | Participants will be administered a placebo prior to paired associative stimulation Receives: Behavioral: Paired Associative stimulation; Drug: Administration of Placebo |
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 minutes Post PAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start11 Mar 2020
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Why it stopped: Closure due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We propose a double-blinded, placebo-controlled crossover study to test a range of doses of escitalopram and a placebo control in enhancing PAS-induced plasticity in healthy individuals without neurological disease and patients with chronic stroke.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- Investigators
- Tomoko Kitago, MD, Principal investigator, Winifred Masterson Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221256
- Sponsor's protocol ID
- HMRL-002
- Status last verified
- Jul 2021
- First submitted
- 6 Jan 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity
- ClinicalTrials.gov ID
- NCT04221256
- Acronym / sponsor ID
- HMRL-002
- Conditions
- Stroke, Ischemic
- Keywords
- Selective Serotonin Reuptake Inhibitor, Neuroplasticity, Paired Associative Stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closure due to COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 9 Jan 2020 (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.
The brain is able to change throughout life in response to learning, or injury, or to adapt to changes in the environment, which is known as neuroplasticity. Stroke survivors suffer disabling chronic motor impairments that have proven challenging to improve. Increasing neuroplasticity using selective serotonin reuptake inhibitors (SSRIs) is a promising approach to promote motor recovery in patients with stroke.
Detailed description
The brain is able to change throughout life in response to learning, or injury, or to adapt to changes in the environment, which is known as neuroplasticity. Stroke survivors suffer disabling chronic motor impairments that have proven challenging to improve. Increasing neuroplasticity using selective serotonin reuptake inhibitors (SSRIs) is a promising approach to promote motor recovery in patients with stroke. Selective serotonin reuptake inhibitors (SSRIs) are currently widely used for treatment of depression, but they also have been shown to be able to enhance neuroplasticity. A single dose of SSRI has been shown to improve hand function in patients with chronic stroke. SSRIs also enhance neuroplasticity in healthy individuals, as shown using paired associative stimulation (PAS), a non-invasive method which causes the brain's excitability to change. However, the best dose of SSRI to increase neuroplasticity is not yet established.
The purpose of this study is to (1) find the effective dose of the SSRI escitalopram to modulate PAS-induced plasticity in patients with stroke and healthy individuals and (2) determine the variability of escitalopram's effect on PAS-induced plasticity between individuals. We measure neuroplasticity with PAS, which causes the brain's excitability to change. During PAS, you would receive electrical stimulation over your wrist and magnetic stimulation to their scalp (called transcranial magnetic stimulation, or TMS) to increase the excitability of the motor area of the brain. You will be asked to participate in a screening visit and 8 study visits separated by at least 1 week. At each study visit, you will be given a single dose of escitalopram (5, 10 or 20) or placebo, and we will measure your brain's change in excitability after PAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We propose a double-blinded, placebo-controlled crossover study to test a range of doses of escitalopram and a placebo control in enhancing PAS-induced plasticity in healthy individuals without neurological disease and patients with chronic stroke.
| Arm | Type | Receives |
|---|---|---|
| Administration of SSRI | Experimental | Drug: Administration of SSRI escitalopram, Behavioral: Paired Associative stimulationParticipants will be administered either 5, 10 or 20mg of SSRI escitalopram prior to paired associative stimulation. |
| Administration of Placebo | Placebo comparator | Behavioral: Paired Associative stimulation, Drug: Administration of PlaceboParticipants will be administered a placebo prior to paired associative stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker
- Current or history of neurological disorders or brain lesions such as stroke, multiple sclerosis, tumor, traumatic brain injury, spinal cord injury
- Diagnosis of major depressive disorder or other psychiatric disorder
- Currently taking escitalopram or another selective serotonin reuptake inhibitor
- Currently taking or have taken in the past month other medications or supplements that have known interactions with escitalopram or can precipitate serotonin syndrome when taken in combination with escitalopram: monoamine oxidase inhibitors, methylene blue, linezolid, serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants (TCAs), fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort
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 |
|---|---|---|
| Administration of SSRI escitalopramParticipants will be administered 5, 10 or 20mg of SRRI escitalopram prior to paired associative stimulation | Drug | Administration of SSRI |
| Paired Associative stimulationParticipants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability. | Behavioural | Administration of Placebo, Administration of SSRI |
| Administration of PlaceboParticipants will be administered a placebo prior to paired associative stimulation | Drug | Administration of Placebo |
Primary outcome
Change in motor evoked potential amplitude
Time frame: Baseline, Up to 30 minutes Post PAS
Assessment of corticospinal excitability
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Tomoko Kitago, MD principal investigator
Winifred Masterson Burke Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Administration of SSRI escitalopram and Paired Associative stimulation in people with Stroke, Ischemic, 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 0 inclusion and 24 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: withdrawn, as of the sponsor's last update on 23 Jul 2021. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 minutes 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 23 Jul 2021.