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Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity

Primary Purpose

Stroke, Ischemic

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Administration of SSRI escitalopram
Paired Associative stimulation
Administration of Placebo
Sponsored by
Burke Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Selective Serotonin Reuptake Inhibitor, Neuroplasticity, Paired Associative Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Neurological Healthy Participants Inclusion criteria

  1. Men and women aged 18 years and older.
  2. Ability to give informed consent.

Exclusion criteria

  1. Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker
  2. Current or history of neurological disorders or brain lesions such as stroke, multiple sclerosis, tumor, traumatic brain injury, spinal cord injury
  3. Diagnosis of major depressive disorder or other psychiatric disorder
  4. Currently taking escitalopram or another selective serotonin reuptake inhibitor
  5. 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
  6. Known hypersensitivity to escitalopram or any of its inactive ingredients.
  7. History of cerebral hemorrhage, gastrointestinal bleeding, or genitourinary bleeding.
  8. History of prolonged QTc
  9. Pregnant or breastfeeding
  10. Social and/or personal circumstances that interfere with the ability to return for all study visits.

Stroke Patients Inclusion criteria

  1. Men and women aged 18 years and older.
  2. Ability to give informed consent.
  3. History of ischemic stroke

Exclusion criteria

  1. Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker
  2. Current or history of neurological disorders or brain lesions such as multiple sclerosis, tumor, traumatic brain injury, spinal cord injury
  3. Diagnosis of major depressive disorder or other psychiatric disorder
  4. Currently taking escitalopram or another selective serotonin reuptake inhibitor
  5. 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
  6. Known hypersensitivity to escitalopram or any of its inactive ingredients.
  7. History of cerebral hemorrhage, gastrointestinal bleeding, or genitourinary bleeding.
  8. History of prolonged QTc
  9. Pregnant or breastfeeding
  10. Social and/or personal circumstances that interfere with the ability to return for all study visits.

Sites / Locations

  • Burke Neurological Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Administration of SSRI

Administration of Placebo

Arm Description

Participants will be administered either 5, 10 or 20mg of SSRI escitalopram prior to paired associative stimulation.

Participants will be administered a placebo prior to paired associative stimulation

Outcomes

Primary Outcome Measures

Change in motor evoked potential amplitude
Assessment of corticospinal excitability

Secondary Outcome Measures

Full Information

First Posted
January 6, 2020
Last Updated
July 19, 2021
Sponsor
Burke Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04221256
Brief Title
Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity
Official Title
Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Closure due to COVID-19 pandemic
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Burke Medical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Selective Serotonin Reuptake Inhibitor, Neuroplasticity, Paired Associative Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Administration of SSRI
Arm Type
Experimental
Arm Description
Participants will be administered either 5, 10 or 20mg of SSRI escitalopram prior to paired associative stimulation.
Arm Title
Administration of Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be administered a placebo prior to paired associative stimulation
Intervention Type
Drug
Intervention Name(s)
Administration of SSRI escitalopram
Intervention Description
Participants will be administered 5, 10 or 20mg of SRRI escitalopram prior to paired associative stimulation
Intervention Type
Behavioral
Intervention Name(s)
Paired Associative stimulation
Intervention Description
Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability.
Intervention Type
Drug
Intervention Name(s)
Administration of Placebo
Intervention Description
Participants will be administered a placebo prior to paired associative stimulation
Primary Outcome Measure Information:
Title
Change in motor evoked potential amplitude
Description
Assessment of corticospinal excitability
Time Frame
Baseline, Up to 30 minutes Post PAS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Neurological Healthy Participants Inclusion criteria Men and women aged 18 years and older. Ability to give informed consent. Exclusion criteria 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. 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 Exclusion criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoko Kitago, MD
Organizational Affiliation
Winifred Masterson Burke Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Neurological Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity

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