StrokeNCT04962698
Robotically Augmented Mental Practice
A study testing Visual motor imagery (MI), Kinesthetic MI and Robotic-Hand Interaction with MI in people with Stroke, run by Georgia Institute of Technology at 1 site in United States.
Trial summary
This project will develop and test a new paradigm of motor imagery for facilitating neuromotor excitability and performance of distal muscles in the upper limb by adopting a robotic prosthesis and integrating proven procedures for neuromotor facilitation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Visual motor imagery (MI), Kinesthetic MI and Robotic-Hand Interaction with MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 16 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-39 years old, men and women
- 21-75 years old
- Right-handed
- Longer than 6 months post-stroke
- Persistent hemiparesis on the right upper extremity (UE)
- Residual UE voluntary movement as indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) and a score of 19-55 on the UE portions of the Fugl Meyer Assessment (UE-FMA)
Show all 42Show fewer
- Preserved cognitive function
- Ability to follow and read simple instructions as indicated by a score of 1 or above on item #9 on the best language items of the NIHSS
- Exclusion Criteria for both healthy and post-stroke individuals: To ensure the safety associated with TMS, the following adults will be excluded (, not applicable to post-stroke subjects):
- Had an adverse reaction to TMS. Had epilepsy or seizure.
- Have any implanted devices such as a neurostimulator or cochlear implant.
- Had a stroke or lesion (including tumor) in your brain*. Had a head injury or brain surgery*.
- Suffer from frequent or severe headaches.
- Had a fainting spell or syncope.
- Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metalwork.
- Have any implanted device such as cardiac pacemakers, medical pumps, or intra-cardiac lines.
- Had any brain-related conditions*.
- Had any illness that caused brain injury* (i.e. meningitis, aneurysm, brain tumor).
- Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion.
- Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia).
- Had more than 2 cups of coffee/caffeinated beverages in the last 12 hours.
- Had more than 2 alcoholic beverages in the last 12 hours.
- Had less than 6 hours of sleep in the last 24 hours.
- Suspected of pregnancy.
- Additional Exclusion Criteria for post-stroke adults:
- A first stroke less than 6 months or more than 24 months prior to the participation.
- Hemiparesis on the left side.
- Hemorrhagic stroke.
- Cerebellar stroke.
- Severe sensory impairment as indicated by the score of 2 (Severe to total sensory loss; the patient is not aware of being touched in the face, arm, and leg) in item #8 (Sensory) of the NIH Stroke Scale (NIHSS).
- Serious uncontrolled medical conditions.
- Severe apraxia of speech.
- Excessive pain in any joint of the more affected extremity that could limit the ability to cooperate with the intervention, as judged by the examining clinician.
- Receiving any anti-spasticity drugs orally at the time of expected participation, 3 months prior, or wish to or is scheduled to receive injections prior to study completion.
- Received phenol injections less than 12 months prior to receiving therapy.
- Unable to stand independently for 2 min., transfer independently to and from the toilet, or perform sit-to-stand.
- A score of less than 24 on the Folstein Mini-Mental State Examination.
- Passive range of motion less than 45 degrees for abduction, flexion or external rotation at the shoulder, or pronation of forearm; or greater than 30 degrees flexion contracture at any finger joint.
- Active range of motion less than 10 degrees for finger flexion or extension.
- Inability to volitionally activate right UE proximal muscles used for EMG placement.
- Clinical judgment of a) a major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures, b) unable to successfully perform all rehabilitation exercise test examples, or c) unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy.
- No TMS response in the first dorsal interosseous muscle in the right hand.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Neuromuscular Physiology Lab
Atlanta, Georgia, 30332
About this study
Official title: Robotically Augmented Mental Practice for Neuromotor Facilitation
This project will develop and test a new paradigm of motor imagery for facilitating neuromotor excitability and performance of distal muscles in the upper limb by adopting a robotic prosthesis and integrating proven procedures for neuromotor facilitation. The scientific purpose of the study is to understand the effect of controlling a detached robotic prosthesis with proximal muscle activation on brain excitability of the resting arm muscles as well as reaction time. The efficacy of this task will be understood by comparing with other task conditions (motor imagery only, 2D visual feedback on a monitor, etc.) that do not involve the robotic prosthesis. The test of the developed system will be performed in healthy able-bodied adults. The feasibility of the system will be examined in post-stroke adults.
Read the detailed description
This study consists of experiments on two non-consecutive days in the Human Neuromuscular Physiology Laboratory located in the Biological Sciences/Applied Physiology Building of Georgia Tech. If subjects qualify and agree to take part in this study, subjects will be asked to read and sign the consent form. The whole procedure will last about 3 hours per day, including preparation. Subjects will come to the lab on two separate days on the same tasks. The first day will serve as familiarization with the same tasks as the second day. Subjects will perform the following experiment. Individuals will sit upright and relax their hands and shoulders. The right hand and forearm will be rested on a plate hidden below a table. The robotic hand will be placed on the table as one would normally place own arm on the table. There will be no physical connection between the hand and the robotic hand. Subjects will activate the abdominal muscles for making a grasping movement of the robotic hand. For making a releasing movement of the robotic hand, subjects will activate the back muscles. Muscle activity will be recorded with two small sensors on each muscle. Subjects will practice activation of each muscle while watching the signal on a monitor. In each muscle, a clearer signal will be used for controlling the robotic digits. Healthy subjects only: Healthy subjects will perform the following tasks A-F. [A: Rest] Subjects will relax the muscles without physical or cognitive effort while gazing at the turned-off monitor. [B: Robotic action observation] Subjects will relax the muscles and focus on observing the computer-controlled grasp and release actions (2 s in each movement) of the robotic prosthesis. [C: Visual MI] Subjects will relax the muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will image the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. [D: Kinesthetic MI] The same MI procedure as Task C will be performed, except that the subjects will focus on the kinesthetic sensation that was felt with the imaged motions. [E: Robotic-Hand Interaction with MI] Subjects will perform robotically augmented mental practice (see below detailed description) for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also image the kinesthetic sensation that was felt with the corresponding motions with the right arm. [F: Virtual-Hand Interaction robot] Subjects will perform Task E with visual feedback of virtual robot actions in 2D on a monitor. [G: Robotic-Hand Interaction without MI] Subjects will perform Task E without MI. As a reaction task, subjects will flex the index finger as soon as they hear an auditory cue. Post-stroke subjects only: Tasks C [Visual MI], E [Robotic-Hand Interaction with MI], and A [Rest] above will be performed by post-stroke subjects with right-side hemiparesis who can volitionally activate fingers and proximal muscles. As a reaction task, subjects will flex the index finger as soon as an auditory cue is heard. TMS (both healthy and post-stroke subjects): During the above-mentioned tasks, brain stimulation (called TMS) will be applied over the motor cortex in the left hemisphere. The TMS procedure will follow the one used in the previous studies by the investigators. A TMS coil will be placed over a precise point on the scalp where the investigators will stimulate the brain to make the muscle move. The investigators will tell the subject when the stimulation portion of the procedure is about to begin. The first part of the procedure will be to find the area of the brain that controls muscles. These investigators will position the TMS coil on the head and will give the subject a series of stimulations (called magnetic pulses). Once the spot that controls the muscles is identified, the investigators will find the least amount of stimulation needed to activate the resting muscles. The second part of the procedure will be to evoke muscle contraction with TMS at rest and during the tasks described above. The investigators will apply TMS with 5-second intervals or more. Robotically augmented practice (Task E and F above): An individual will use proximal muscle contractions to flex and extend the robotic prosthesis digits for performing a grasp-release task. 1) Grasp. The individual will activate the proximal muscles as if for a retrieving motion (the back muscles) for 2 s. This muscle activation controls the robotic hand to flex the digits to grasp a cylinder-shaped object. 2) Release. The individual will relax the above-activated proximal muscles and activate the proximal muscles as if for a reaching motion (the abdominal muscles) for 2 s. This muscle activation controls the robotic hand to extend the digits to release the object. After releasing the object, the individual will relax the proximal muscles. The individual will repeat this sequence while observing and hearing the actions of the robotic hand.
- Conditions
- Stroke
- Being tested
- Visual motor imagery (MI), Kinesthetic MI, Robotic-Hand Interaction with MI, Robotic-Hand Interaction without MI, Virtual-Hand Interaction
- Keywords
- Hand, Imagery, Robot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual motor imagery (MI)Behavioural
Subjects will relax their muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction.
Kinesthetic MIBehavioural
The same MI procedure as Visual MI will be performed, except that the subjects will focus on the kinesthetic sensation that they would feel with the imagined motions.
Robotic-Hand Interaction with MIBehavioural
Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm.
Robotic-Hand Interaction without MIBehavioural
Subjects will perform the Robot-Hand Interaction without MI.
Virtual-Hand InteractionBehavioural
Subjects will interact with visual feedback of virtual robot actions on a monitor.
Robotic Action ObservationBehavioural
Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand.
RestBehavioural
Subjects will rest without a task.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | All participants will receive seven types of interventions in random order. The types of interventions are the same across subjects. Receives: Behavioral: Visual motor imagery (MI); Behavioral: Kinesthetic MI; Behavioral: Robotic-Hand Interaction with MI; Behavioral: Robotic-Hand Interaction without MI; Behavioral: Virtual-Hand Interaction; Behavioral: Robotic Action Observation; Behavioral: Rest |
| Post-Stroke participants | Experimental | All participants will receive three types of interventions in random order. The types of interventions are the same across subjects. Receives: Behavioral: Visual motor imagery (MI); Behavioral: Robotic-Hand Interaction with MI; Behavioral: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP Amplitude
Peak-to-peak amplitude of motor evoked potential (MEP) of the hand muscle
Measured: 1 day
Reaction Time
Reaction time of the index finger in response to an auditory cue (reaction time test)
Measured: 1 day
Peak EMG
Peak EMG amplitude of the hand muscle during the reaction time test was determined in each intervention. After identifying the maximal peak EMG value among the interventions, peak EMG value in each task was normalized to that maximal peak EMG, expressed as the ratio.
Measured: 1 day
Maximal Rate of Force Development
Maximal rate of force development during a reaction time test
Measured: 1 day
Peak Force
Peak force of the index finger during a reaction time test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start11 May 2022
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants in a single group will receive various types of interventions in random order. The types of interventions are the same across subjects.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Minoru Shinohara, Ph.D., Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962698
- Sponsor's protocol ID
- H21154
- Other IDs
- R21NS118435
- Status last verified
- Aug 2023
- First submitted
- 2 Jul 2021
- Last updated
- 19 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotically Augmented Mental Practice for Neuromotor Facilitation
- ClinicalTrials.gov ID
- NCT04962698
- Acronym / sponsor ID
- H21154
- Conditions
- Stroke
- Keywords
- Hand, Imagery, Robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Posted 19 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will develop and test a new paradigm of motor imagery for facilitating neuromotor excitability and performance of distal muscles in the upper limb by adopting a robotic prosthesis and integrating proven procedures for neuromotor facilitation. The scientific purpose of the study is to understand the effect of controlling a detached robotic prosthesis with proximal muscle activation on brain excitability of the resting arm muscles as well as reaction time. The efficacy of this task will be understood by comparing with other task conditions (motor imagery only, 2D visual feedback on a monitor, etc.) that do not involve the robotic prosthesis. The test of the developed system will be performed in healthy able-bodied adults. The feasibility of the system will be examined in post-stroke adults.
Detailed description
This study consists of experiments on two non-consecutive days in the Human Neuromuscular Physiology Laboratory located in the Biological Sciences/Applied Physiology Building of Georgia Tech. If subjects qualify and agree to take part in this study, subjects will be asked to read and sign the consent form. The whole procedure will last about 3 hours per day, including preparation. Subjects will come to the lab on two separate days on the same tasks. The first day will serve as familiarization with the same tasks as the second day. Subjects will perform the following experiment. Individuals will sit upright and relax their hands and shoulders. The right hand and forearm will be rested on a plate hidden below a table. The robotic hand will be placed on the table as one would normally place own arm on the table. There will be no physical connection between the hand and the robotic hand. Subjects will activate the abdominal muscles for making a grasping movement of the robotic hand. For making a releasing movement of the robotic hand, subjects will activate the back muscles. Muscle activity will be recorded with two small sensors on each muscle. Subjects will practice activation of each muscle while watching the signal on a monitor. In each muscle, a clearer signal will be used for controlling the robotic digits. Healthy subjects only: Healthy subjects will perform the following tasks A-F. [A: Rest] Subjects will relax the muscles without physical or cognitive effort while gazing at the turned-off monitor. [B: Robotic action observation] Subjects will relax the muscles and focus on observing the computer-controlled grasp and release actions (2 s in each movement) of the robotic prosthesis. [C: Visual MI] Subjects will relax the muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will image the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. [D: Kinesthetic MI] The same MI procedure as Task C will be performed, except that the subjects will focus on the kinesthetic sensation that was felt with the imaged motions. [E: Robotic-Hand Interaction with MI] Subjects will perform robotically augmented mental practice (see below detailed description) for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also image the kinesthetic sensation that was felt with the corresponding motions with the right arm. [F: Virtual-Hand Interaction robot] Subjects will perform Task E with visual feedback of virtual robot actions in 2D on a monitor. [G: Robotic-Hand Interaction without MI] Subjects will perform Task E without MI. As a reaction task, subjects will flex the index finger as soon as they hear an auditory cue. Post-stroke subjects only: Tasks C [Visual MI], E [Robotic-Hand Interaction with MI], and A [Rest] above will be performed by post-stroke subjects with right-side hemiparesis who can volitionally activate fingers and proximal muscles. As a reaction task, subjects will flex the index finger as soon as an auditory cue is heard. TMS (both healthy and post-stroke subjects): During the above-mentioned tasks, brain stimulation (called TMS) will be applied over the motor cortex in the left hemisphere. The TMS procedure will follow the one used in the previous studies by the investigators. A TMS coil will be placed over a precise point on the scalp where the investigators will stimulate the brain to make the muscle move. The investigators will tell the subject when the stimulation portion of the procedure is about to begin. The first part of the procedure will be to find the area of the brain that controls muscles. These investigators will position the TMS coil on the head and will give the subject a series of stimulations (called magnetic pulses). Once the spot that controls the muscles is identified, the investigators will find the least amount of stimulation needed to activate the resting muscles. The second part of the procedure will be to evoke muscle contraction with TMS at rest and during the tasks described above. The investigators will apply TMS with 5-second intervals or more. Robotically augmented practice (Task E and F above): An individual will use proximal muscle contractions to flex and extend the robotic prosthesis digits for performing a grasp-release task. 1) Grasp. The individual will activate the proximal muscles as if for a retrieving motion (the back muscles) for 2 s. This muscle activation controls the robotic hand to flex the digits to grasp a cylinder-shaped object. 2) Release. The individual will relax the above-activated proximal muscles and activate the proximal muscles as if for a reaching motion (the abdominal muscles) for 2 s. This muscle activation controls the robotic hand to extend the digits to release the object. After releasing the object, the individual will relax the proximal muscles. The individual will repeat this sequence while observing and hearing the actions of the robotic hand.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in a single group will receive various types of interventions in random order. The types of interventions are the same across subjects.
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Behavioral: Visual motor imagery (MI), Behavioral: Kinesthetic MI, Behavioral: Robotic-Hand Interaction with MI, Behavioral: Robotic-Hand Interaction without MI, Behavioral: Virtual-Hand Interaction, Behavioral: Robotic Action Observation, Behavioral: RestAll participants will receive seven types of interventions in random order. The types of interventions are the same across subjects. |
| Post-Stroke participants | Experimental | Behavioral: Visual motor imagery (MI), Behavioral: Robotic-Hand Interaction with MI, Behavioral: RestAll participants will receive three types of interventions in random order. The types of interventions are the same across subjects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- 18-39 years old, men and women
- 21-75 years old
- Right-handed
- Longer than 6 months post-stroke
- Persistent hemiparesis on the right upper extremity (UE)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Visual motor imagery (MI)Subjects will relax their muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. | Behavioural | Healthy participants, Post-Stroke participants |
| Kinesthetic MIThe same MI procedure as Visual MI will be performed, except that the subjects will focus on the kinesthetic sensation that they would feel with the imagined motions. | Behavioural | Healthy participants |
| Robotic-Hand Interaction with MISubjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. | Behavioural | Healthy participants, Post-Stroke participants |
| Robotic-Hand Interaction without MISubjects will perform the Robot-Hand Interaction without MI. | Behavioural | Healthy participants |
| Virtual-Hand InteractionSubjects will interact with visual feedback of virtual robot actions on a monitor. | Behavioural | Healthy participants |
| Robotic Action ObservationSubjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand. | Behavioural | Healthy participants |
| RestSubjects will rest without a task. | Behavioural | Healthy participants, Post-Stroke participants |
Primary outcome
MEP Amplitude
Time frame: 1 day
Peak-to-peak amplitude of motor evoked potential (MEP) of the hand muscle
Reaction Time
Time frame: 1 day
Reaction time of the index finger in response to an auditory cue (reaction time test)
Peak EMG
Time frame: 1 day
Peak EMG amplitude of the hand muscle during the reaction time test was determined in each intervention. After identifying the maximal peak EMG value among the interventions, peak EMG value in each task was normalized to that maximal peak EMG, expressed as the ratio.
Maximal Rate of Force Development
Time frame: 1 day
Maximal rate of force development during a reaction time test
Peak Force
Time frame: 1 day
Peak force of the index finger during a reaction time test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Minoru Shinohara, Ph.D. principal investigator
Georgia Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual motor imagery (MI), Kinesthetic MI and Robotic-Hand Interaction with MI in people with Stroke, run by Georgia Institute of Technology 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 42 inclusion and 0 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 19 Oct 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MEP Amplitude (time frame: 1 day). The study lists 5 primary outcomes in all. 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 19 Oct 2023.