StrokePhase 1PHATHOMNCT07053917
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
A Phase 1 study testing Psilocybin (Usona Institute) in people with Stroke and Chronic Stroke, run by Johns Hopkins University at 1 site in United States.
Trial summary
The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Chronic Stroke, Intracerebral Haemorrhage
- What is being tested?
- Psilocybin (Usona Institute)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over age 18 years, inclusive.
- Ischemic or hemorrhagic stroke confirmed by CT or MRI, at least 12 months prior to admission date
- Ability to give informed consent and understand the tasks involved.
- Agree that, for the study duration, will refrain from: (1) No new prescription medications during the time of the study without approval of the study team, (2) taking any herbal supplement (except with prior approval of the research team), (3) taking any nonprescription medications with the exception of: 1. non-steroidal anti-inflammatory drugs. 2. acetaminophen. 3. vitamins. 4. or other over-the-counter medications approved by the research team
- Are willing to follow restrictions and guidelines concerning medications, consumption of food, beverages, and nicotine the night before and just prior to psilocybin administration.
- Agree to have transportation other than driving themselves home or to where the participants are staying after the administration of psilocybin.
Show all 13Show fewer
- Are willing to be contacted via telephone for all necessary telephone contacts.
- Must have a negative pregnancy test if able to bear children.
- Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal.
- Must agree to inform the investigators within 48 hours of any new medical conditions and procedures.
- Are proficient in speaking and reading English.
- Agree to have all clinical visit sessions recorded to audio and video.
- Agree to not participate in any other interventional clinical trials during the duration of this study.
Who cannot join
- Taking one of the following medications in the 30 days prior to psilocybin administration:
- selective serotonin reuptake inhibitor (SSRI)
- Serotonin-norepinephrine reuptake inhibitors (SNRI)
- Buproprion
- Valproic acid
- Zolpidem
Show all 38Show fewer
- Trazodone
- Carbamazepine.
- tricyclic antidepressants
- Monoamine Oxidase Inhibitors
- Mirtazapine
- Lithium m. Buspirone n. Atypical antipsychotics o. Zolpidem p.Carbamazepine q. Clonazepam r. Gabapentin s. Lamotrigine t. Levetiracetam u. Phenobarbital v. Phenytoin w. Topiramate x. Valproic Acid y. Zonisamide
- History of medically significant suicide attempt.
- Evidence of acute cardiac dysfunction as evidenced by either elevated troponin or EKG changes within 48 hours of administration.
- Systolic blood pressure that is greater than 150 mmHg systolic on > 2 readings during the 7-day monitoring period AND blood pressure medication management has been assured.
- Diastolic blood pressure that is greater than 100 mmHg systolic on > 2 readings during the 7-day monitoring period AND blood pressure medication management has been assured.
- Systolic blood pressure is less than 90 mmHg systolic on > 2 readings during the 7-day monitoring period after blood pressure medication management has been assured.
- Diastolic blood pressure is less than 30 mmHg systolic on > 2 readings during the 7-day monitoring period after blood pressure medication management has been assured.
- Systolic blood pressure exceeds 160 mmHg or is less than 90 mmHg immediately prior to administration of psilocybin; patients are allowed to be on anti-hypertensives.
- Diastolic blood pressure exceeds 100 mmHg or is less than 30 mmHg immediately prior to administration of psilocybin; patients are allowed to be on anti-hypertensives.
- Cognitive impairment that, in the estimation of the study team, would preclude the use of the MindPod Dolphin.
- History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
- Social and/or personal circumstances that interfere with ability to perform follow up assessments.
- Are pregnant or nursing.
- Weigh less than 48 kg.
- Are not able to give adequate informed consent.
- Are actively abusing opioids, cocaine, Phencyclidine (PCP), amphetamines, or alcohol.
- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5) criteria for moderate or severe substance use disorder
- Diagnosis of schizophrenia, history of prior psychosis, anxiety requiring hospitalization, or Type 1 bipolar.
- Hypernatremia
- Hypokalemia (but can have received repletion during the prior 24 hours)
- Hyperkalemia
- Glomerular filtration rate of < 30 ml/min
- Elevated of white blood cell count
- Hemoglobin < 7 g/dl
- Platelet count < 100,000 g/dl
- Acute cardiac dysfunction demonstrated by either troponin elevation (chronic elevation is acceptable), or EKG changes suggestive of acute coronary syndrome.
- Active suicidal ideation as assess by the C-SSRS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Victor C Urrutia, M.D. contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21287
About this study
The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.
Read the detailed description
Stroke is the leading cause of death and adult disability worldwide, and every year more than 795,000 people in the United States have a stroke. According to the National Stroke Association, only 10 percent of people who have a stroke recover completely, while 50 percent experience moderate to severe long-term disability, including significant impairment in language, cognition, motor, and sensory skills, which require special care or long-term care in a nursing home or other facility. Therefore, in the United States alone, nearly 400,000 people per year will suffer the lasting debilitating consequences of stroke. Previous studies have indicated that rehabilitation following stroke is constrained by a so-called 'critical' or 'sensitive' period. While this learning window can be extended or enhanced, once the post-stroke rehabilitation critical period has closed, clinically applicable manipulations that can reopen it are lacking.
Recently the investigators have shown that the psychedelic compounds like psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxmethamphetamine (MDMA) can reopen a novel critical period for social reward learning. The adage "you can't teach an old dog new tricks" captures a certain truth about the brain. Specifically, a young person's brain is much more malleable (e.g., able to make new motor-memories and store new motor-memories) compared to an adult's brain. Neuroscientists call these periods of heightened sensitivity to input "critical periods." Based on these observations the investigators posit that psychedelic compounds serve as the long sought-after "master key" for unlocking critical periods across the brain. Ongoing preclinical studies are examining this possibility, with the goal of determining the therapeutic potential of psychedelics (including psilocybin) as adjunct therapies for any intervention whose clinical efficacy may be constrained by critical period closure, including post-stroke rehabilitation.
The main purpose of the proposed studies is to evaluate the safety and tolerability of psilocybin in stroke patients (Phase 1). as a secondary aim the investigators will collect data on the efficacy of psilocybin in effecting motor recovery in post-stroke patients.
- Conditions
- Stroke, Chronic Stroke, Intracerebral Haemorrhage, Intracerebral Haemorrhage (ICH), Intracerebral Hemorrhage Basal Ganglia, Ischemic Stroke
- Being tested
- Psilocybin (Usona Institute)
- Keywords
- psychedelic, stroke, chronic stroke, intracerebral hemorrhage, stroke recovery, motor recovery, poststroke recovery, poststroke motor recovery, hemiparesis recovery, psychedelic safety
- Medical subject headings
- Stroke, Cerebral Hemorrhage, Ischemic Stroke, Hemorrhagic Stroke, Hemiplegia, Paresis, Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (Usona Institute)Drug
Participants will receive psilocybin to test its safety. Secondary outcomes will assess recovery from post-stroke deficits.
| Study group | Role | What they receive |
|---|---|---|
| 25 mg of psilocybin | Experimental | Participants will receive 25 mg of psilocybin Receives: Drug: Psilocybin (Usona Institute) |
| 12.5 mg + 12.5 mg of psilocybin | Experimental | Participants will receive 12.5 mg of psilocybin followed by another 12.5 mg of psilocybin 2 hours after the first dose. Receives: Drug: Psilocybin (Usona Institute) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of systolic and diastolic blood pressure (mmHg)
Will be measuring the number of participants that meet these criteria:
- no sustained elevation of systolic blood pressure of more than 180 mmHg on more than two readings sustained for more than 20 minutes.
- no sustained elevation of diastolic blood pressure of more that 120 mmHg on more than two reading sustained for more than 20 minutes.
- No sustained reduction of systolic blood pressure of less than 70 mmHg on more than two readings sustained for more than 20 minutes.
- No sustained reduction of diastolic blood pressure of less than 40 mmHg on more than two readings sustained for more than 20 minutes
Measured: up to 24 hours post-psilocybin administration
Secondary outcomes (22)
Number of adverse changes in vital signs that require medical attention
Adverse change in vital signs, not otherwise meeting specified outcome criteria, that a treating provider feels requires medical intervention.
Measured: up to 24 hours post-psilocybin administration
Number of changes in psychiatric symptoms that require medical intervention
Significant psychiatric symptoms within 24 hours post-dosing as determined by clinical staff to require medical intervention
Measured: up to 24 hours post-psilocybin administration
Stability of pulse assessed by heart rate monitoring
no resting tachycardia for more than 20 minutes defined as heart rate greater than 110 bpm, or resting bradycardia for more than 20 minutes defined as less than 40 bpm.
Measured: up to 24 hours post-psilocybin administration
Oxygen Percent Saturation
Stability of pulse oximetry. No reduction of percent saturation of less than 87% as assess by pulse oximetry on more than two readings sustained for more than 10 minutes.
Measured: up to 24 hours post-psilocybin administration
Number of participants with no change in EKG suggestive of ischemia
No change in EKG suggestive of ischemia
Measured: up to 24 hours post-psilocybin administration
Number of participants without seizures
No seizures assessed by clinical observation and examination
Measured: up to 24 hours post-psilocybin administration
Number of Participants without elevation of cardiac troponin
Troponin assessed by serum quantification
Measured: up to 24 hours post-psilocybin administration
Suicidal ideation assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C- SSRS) before, during and after experimental sessions and on selected days of telephone or face-to-face contact. Score range 0-25 with higher scores indicating more severe suicidal ideation.
Measured: Day 1, prior to dosing-24 hours post-dosing (+/- 5 hours) weekly, up to 3 weeks
Number of deviations from pre-dosing electrolyte levels as assessed by CMP
Deviation from pre-dosing values of sodium, potassium, chlorine, and calcium, will be assessed by comprehensive metabolic panel (CMP)
Measured: Pre-dosing and between 8 and 24 hours post-psilocybin dosing
Neurologic Impairment as assessed by The National Institutes of Health Stroke Scale (NIHSS)
Secondary recovery outcome. Scores range from 0 to 42, with higher scores indicating increasing severity
Measured: 30 days and 90 days
Motor Function as assessed by the Fugl-Meyer Upper Extremity Motor Assessment (FM-UE)
Secondary recovery outcome. The score range is 0 to 66. A lower score indicates impaired motor function in the upper extremity assessed.
Measured: 30 days and 90 days
Amount of recovery of arm-hand function as assessed by the Action Research Arm Test (ARAT)
Secondary recovery outcome. Scores range from 0-to-57 with a higher score indicating a better outcome.
Measured: 30 days and 90 days
Global disability as assessed by the Modified Rankin Scales (mRS)
Secondary recovery outcome. Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.
Measured: 30 days and 90 days
Function as assessed by the Barthel Index (BI)
Secondary recovery outcome. Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
Measured: 30 days and 90 days
Montreal cognitive assessment (MOCA)
Secondary recovery outcome. MOCA score ranges from 0-30, with higher score being better performance.
Measured: 30 days and 90 days
Digital hand kinematics
Secondary recovery outcome. Change in fingertip individuation index as assessed by kinematic measurement of digit movement using a device that uses sensor-based technology to capture joint range of motion. Full extension and flexion of each digit in isolation will be captured using this technology and compared.
Measured: 30 days and 90 days
Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
Secondary recovery outcome. The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Participants are asked to place pegs into the holes one at a time, then remove them one at a time, and place them back in the container as fast as they can.
Measured: 30 days and 90 days
Grasp Performance
Secondary recovery outcome. Change in gross grasp will be measured using dynamometry in pours of force output. three measure will be take on the right and left hand and the value will be averaged using a calibrated dynamometer. greater force output is equal to greater grip strength.
Measured: 30 and 90 days
10m walk time
Secondary Recovery Outcome. Patients are asked to walk 10m. faster is better.
Measured: 30 days and 90 days
Depression as assessed by the Patient Health Questionnaire (PHQ)
Secondary recovery outcome. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (range of 0-27)
Measured: 30 days and 90 days
Stroke Impact Scale (SIS)-16
The Stroke Impact Scale (SIS)-16 consists of 16 items from the 4 physical domains (strength, hand function, mobility, and ADL/IADL) to assess recovery post-stroke. Total score ranges between 0-100; higher scores are better.
Measured: 90 days
Secondary recovery outcome - post-study assessment survey
Survey designed to assay participant's enjoyment and self-assessed recovery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start9 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
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.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Rose Hill, Usona Institute, University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Victor Urrutia, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053917
- Sponsor's protocol ID
- IRB00274773
- Acronym
- PHATHOM
- Status last verified
- Feb 2026
- First submitted
- 30 May 2025
- Last updated
- 13 Feb 2026
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
- ClinicalTrials.gov ID
- NCT07053917
- Acronym / sponsor ID
- PHATHOM / IRB00274773
- Conditions
- Stroke, Chronic Stroke, Intracerebral Haemorrhage, Intracerebral Haemorrhage (ICH), Intracerebral Hemorrhage Basal Ganglia, Ischemic Stroke
- Keywords
- psychedelic, stroke, chronic stroke, intracerebral hemorrhage, stroke recovery, motor recovery, poststroke recovery, poststroke motor recovery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Rose Hill, Usona Institute, University of California, Berkeley
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Jul 2025 (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 main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.
Detailed description
Stroke is the leading cause of death and adult disability worldwide, and every year more than 795,000 people in the United States have a stroke. According to the National Stroke Association, only 10 percent of people who have a stroke recover completely, while 50 percent experience moderate to severe long-term disability, including significant impairment in language, cognition, motor, and sensory skills, which require special care or long-term care in a nursing home or other facility. Therefore, in the United States alone, nearly 400,000 people per year will suffer the lasting debilitating consequences of stroke. Previous studies have indicated that rehabilitation following stroke is constrained by a so-called 'critical' or 'sensitive' period. While this learning window can be extended or enhanced, once the post-stroke rehabilitation critical period has closed, clinically applicable manipulations that can reopen it are lacking.
Recently the investigators have shown that the psychedelic compounds like psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxmethamphetamine (MDMA) can reopen a novel critical period for social reward learning. The adage "you can't teach an old dog new tricks" captures a certain truth about the brain. Specifically, a young person's brain is much more malleable (e.g., able to make new motor-memories and store new motor-memories) compared to an adult's brain. Neuroscientists call these periods of heightened sensitivity to input "critical periods." Based on these observations the investigators posit that psychedelic compounds serve as the long sought-after "master key" for unlocking critical periods across the brain. Ongoing preclinical studies are examining this possibility, with the goal of determining the therapeutic potential of psychedelics (including psilocybin) as adjunct therapies for any intervention whose clinical efficacy may be constrained by critical period closure, including post-stroke rehabilitation.
The main purpose of the proposed studies is to evaluate the safety and tolerability of psilocybin in stroke patients (Phase 1). as a secondary aim the investigators will collect data on the efficacy of psilocybin in effecting motor recovery in post-stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 mg of psilocybin | Experimental | Drug: Psilocybin (Usona Institute)Participants will receive 25 mg of psilocybin |
| 12.5 mg + 12.5 mg of psilocybin | Experimental | Drug: Psilocybin (Usona Institute)Participants will receive 12.5 mg of psilocybin followed by another 12.5 mg of psilocybin 2 hours after the first dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Over age 18 years, inclusive.
- Ischemic or hemorrhagic stroke confirmed by CT or MRI, at least 12 months prior to admission date
- Ability to give informed consent and understand the tasks involved.
- Agree that, for the study duration, will refrain from: (1) No new prescription medications during the time of the study without approval of the study team, (2) taking any herbal supplement (except with prior approval of the research team), (3) taking any nonprescription medications with the exception of: 1. non-steroidal anti-inflammatory drugs. 2. acetaminophen. 3. vitamins. 4. or other over-the-counter medications approved by the research team
- Are willing to follow restrictions and guidelines concerning medications, consumption of food, beverages, and nicotine the night before and just prior to psilocybin administration.
Key exclusion criteria (38 listed)
- Taking one of the following medications in the 30 days prior to psilocybin administration:
- History of medically significant suicide attempt.
- Evidence of acute cardiac dysfunction as evidenced by either elevated troponin or EKG changes within 48 hours of administration.
- Systolic blood pressure that is greater than 150 mmHg systolic on > 2 readings during the 7-day monitoring period AND blood pressure medication management has been assured.
- Diastolic blood pressure that is greater than 100 mmHg systolic on > 2 readings during the 7-day monitoring period AND blood pressure medication management has been assured.
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 |
|---|---|---|
| Psilocybin (Usona Institute)Participants will receive psilocybin to test its safety. Secondary outcomes will assess recovery from post-stroke deficits. | Drug | 12.5 mg + 12.5 mg of psilocybin, 25 mg of psilocybin |
Primary outcome
Stability of systolic and diastolic blood pressure (mmHg)
Time frame: up to 24 hours post-psilocybin administration
Will be measuring the number of participants that meet these criteria: 1. no sustained elevation of systolic blood pressure of more than 180 mmHg on more than two readings sustained for more than 20 minutes. 2. no sustained elevation of diastolic blood pressure of more that 120 mmHg on more than two reading sustained for more than 20 minutes. 3. No sustained reduction of systolic blood pressure of less than 70 mmHg on more than two readings sustained for more than 20 minutes. 4. No sustained reduction of diastolic blood pressure of less than 40 mmHg on more than two readings sustained for more than 20 minutes
22 secondary outcomes
Number of adverse changes in vital signs that require medical attention
Time frame: up to 24 hours post-psilocybin administration
Number of changes in psychiatric symptoms that require medical intervention
Time frame: up to 24 hours post-psilocybin administration
Stability of pulse assessed by heart rate monitoring
Time frame: up to 24 hours post-psilocybin administration
Oxygen Percent Saturation
Time frame: up to 24 hours post-psilocybin administration
Number of participants with no change in EKG suggestive of ischemia
Time frame: up to 24 hours post-psilocybin administration
Number of participants without seizures
Time frame: up to 24 hours post-psilocybin administration
Number of Participants without elevation of cardiac troponin
Time frame: up to 24 hours post-psilocybin administration
Suicidal ideation assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 1, prior to dosing-24 hours post-dosing (+/- 5 hours) weekly, up to 3 weeks
Number of deviations from pre-dosing electrolyte levels as assessed by CMP
Time frame: Pre-dosing and between 8 and 24 hours post-psilocybin dosing
Neurologic Impairment as assessed by The National Institutes of Health Stroke Scale (NIHSS)
Time frame: 30 days and 90 days
Motor Function as assessed by the Fugl-Meyer Upper Extremity Motor Assessment (FM-UE)
Time frame: 30 days and 90 days
Amount of recovery of arm-hand function as assessed by the Action Research Arm Test (ARAT)
Time frame: 30 days and 90 days
Global disability as assessed by the Modified Rankin Scales (mRS)
Time frame: 30 days and 90 days
Function as assessed by the Barthel Index (BI)
Time frame: 30 days and 90 days
Montreal cognitive assessment (MOCA)
Time frame: 30 days and 90 days
Digital hand kinematics
Time frame: 30 days and 90 days
Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
Time frame: 30 days and 90 days
Grasp Performance
Time frame: 30 and 90 days
10m walk time
Time frame: 30 days and 90 days
Depression as assessed by the Patient Health Questionnaire (PHQ)
Time frame: 30 days and 90 days
Stroke Impact Scale (SIS)-16
Time frame: 90 days
Secondary recovery outcome - post-study assessment survey
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
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.
Victor C Urrutia, M.D. contact
Victor Urrutia, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin (Usona Institute) in people with Stroke and Chronic Stroke, run by Johns Hopkins University 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 13 inclusion and 38 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven R Zeiler, M.D., Ph.D. (303-520-7404, sz@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of systolic and diastolic blood pressure (mmHg) (time frame: up to 24 hours post-psilocybin administration). 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 13 Feb 2026.