Spinal Cord InjuriesPhase 1NCT05708274
Pharmacological Agents for Chronic Spinal Cord Injury (SCI)
A Phase 1 study testing CPH + hand training, CD-LD + hand training and ATX + hand training in people with Spinal Cord Injuries, run by Bronx VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the short-term effects of 3 approved FDA drugs (cyproheptadine (CPH), carbidopa-levodopa (CD-LD), and atomoxetine (ATX)) on motor responses when delivered in combination with hand training exercises in people with chronic spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- CPH + hand training, CD-LD + hand training and ATX + hand training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 30 Oct 2025
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years of age; clinically stable chronic (> 12 months) SCI at or above C8 spinal segment;
- Motor-incomplete with a score of 2 or more (out of 5) on manual muscle testing (MMT) of finger extension, finger flexion, or finger abduction in left or right hand(s); or able to perform thumb-index finger pinch of the left or right hand;
- Detectable stimulation-evoked muscle responses of the left or right first dorsal interosseous (FDI) and/or abductor pollicis brevis (APB); Detectable FDI/APB surface electromyography (EMG) muscle activity during thumb-index finger pinch;
- Must have stable: medication [≥ 30 days prior]; rehabilitation regimen [≥ 15 days prior];
- Must be able to: abstain from alcohol, smoking and caffeine consumption on the day prior/of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 7 visits); provide informed consent.
Who cannot join
- History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
- History of other serious central or peripheral neurological injury;
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain stimulation or task performance;
- Ventilator dependence or patent tracheostomy site;
- Unstable syrinx, or multiple spinal cord lesions;
- Unclear diagnosis; History of stroke, brain tumor, brain abscess, or multiple sclerosis;
Show all 16Show fewer
- Personal history of seizures; extensive family history of seizures; use of medications that lower seizure threshold (e.g., amphetamines, dalfampridine, and bupropion);
- Use of the study medications; Use of medications known to have significant adverse interactions with the study medication as described in the manufacturers' prescribing information [14 days prior]; previous allergic reaction or hypersensitivity to study drug(s);
- Presence of a medical condition that represents a risk for study drug(s) administration; evidence of liver disease or clinical jaundice; neutropenia; glaucoma; gastrointestinal ulcer(s); active malignancy; undiagnosed skin lesions; autoimmune disorders; chronic infectious diseases (e.g. HIV, hepatitis B or C); pregnancy or nursing mothers (a pregnancy urine test may be warranted); neurologic disorders (including a history of serious head trauma or seizures), and uncontrolled cardiovascular, metabolic, pulmonary or renal disease; premorbid, ongoing major depression or psychosis, altered cognitive status; bipolar disorder; suicidal ideation or past suicide attempts;
- History of severe hearing problems, loss or tinnitus;
- Presence of urinary infection, fever, pressure ulcer; or open skin lesions (shoulders or arms);
- Recent history (< 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in HR, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (closely monitored during all testing procedures);
- Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous 48 hours;
- Recent history (>1 year) of chemical substance dependency or significant psychosocial disturbance;
- Study participation of an investigational drug or device [60 days prior];
- Unsuitable for study participation as determined by the study physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
About this study
Official title: The Role of Pharmacological Agents in Restoring Neuronal Excitability After Chronic Spinal Cord Injury (SCI)
The purpose of this study is to investigate the short-term effects of 3 approved FDA drugs (cyproheptadine (CPH), carbidopa-levodopa (CD-LD), and atomoxetine (ATX)) on motor responses when delivered in combination with hand training exercises in people with chronic spinal cord injury. The goal is to learn how to better strengthen connections between the brain and spinal cord after spinal cord injury, and if this connection is improved by one(or more) of the drugs. Multiple aspects of nerve transmission and muscle response will be measured via noninvasive brain and spinal cord stimulation, along with motor performance (dexterity and strength).
Read the detailed description
Research will take place at the James J. Peters VA Medical Center (JJPVAMC), Bronx, NY. There are seven visits in total, including an initial evaluation and clinical assessment session. Each visit will last roughly 5 hours or less. We plan to enroll 28 participants with spinal cord injury over a two-year period.
The study is designed as a double-blind, placebo-controlled, single-dose, randomized crossover investigation involving four study drug visits (CPH, CD-LD, ATX, or placebo).
The same participants will partake in all four interventions in randomized order with at least 1-week washout representative of greater than 5x drug half-life; to avoid accumulative effects. To reduce potential learning effects from motor training and task-related outcome measurements, participants will partake in two motor training practice sessions prior to commencing the experiments for task familiarity.
This study will consist of electromyography (surface recordings of muscle activity), peripheral nerve stimulation, transcranial magnetic brain stimulation (TMS), and transcutaneous electrical spinal cord stimulation (TSCS), targeting the hand/arm muscles.
Though it is unlikely given the single-dose nature, participants may experience side effects following drug administration. Prior to consenting, all volunteers will undergo a comprehensive pre-screening evaluation including blood tests to ensure there are no contraindications.
Please note, there is no expectation of long-term benefit from this study.
- Conditions
- Spinal Cord Injuries
- Being tested
- CPH + hand training, CD-LD + hand training, ATX + hand training, Placebo + hand training
- Keywords
- Transcranial magnetic stimulation, Pharmacological agents, Transcutaneous spinal cord stimulation, Hand exercise
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPH + hand trainingDrug
Following a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements.
CD-LD + hand trainingDrug
Following a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements.
ATX + hand trainingDrug
Following a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements.
Placebo + hand trainingDrug
Following a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements.
| Study group | Role | What they receive |
|---|---|---|
| CPH + hand training | Experimental | A single dose of Cyproheptadine (CPH) (8 mg) will be administered. Supplied as 2 over-encapsulated pills of 4 mg each. Receives: Drug: CPH + hand training |
| CD-LD + hand training | Experimental | A single dose of IR Carbidopa-levodopa (CD-LD) (50/200 mg) will be administered. Supplied as 2 over-encapsulated pills (25 mg carbidopa / 100 mg levodopa each). Receives: Drug: CD-LD + hand training |
| ATX + hand training | Experimental | A single dose of Atomoxetine (ATX) (40 mg) will be administered. Supplied as 1 over-encapsulated pill of 40 mg plus 1 placebo capsule. Receives: Drug: ATX + hand training |
| Placebo + hand training | Placebo comparator | A single dose of Placebo will be administered. Supplied as 2 gelatin capsules, identical in number, size, shape and color, filled with microcrystalline cellulose. Receives: Drug: Placebo + hand training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing task performance (dexterity)
Unilateral manual dexterity will be assessed using the 9-Hole Peg Test (Aim 1a).
Measured: Assess change from baseline to 10 minutes after completion of drug+task training.
Secondary outcomes (12)
Assessing task performance (dexterity)
Unilateral manual dexterity will be assessed using the Box and Block Test (Aim 1a).
Measured: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing volitional grip strength
Maximal grip force will be measured (Aim 1b). The attempt with the highest value will be used for analysis.
Measured: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing volitional pinch strength
Maximal pinch force will be measured (Aim 1b). The attempt with the highest value will be used for analysis.
Measured: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing corticospinal plasticity
Corticospinal plasticity will be measured via single-pulse TMS recruitment curves (Aim 2a).
Measured: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing cortical plasticity
Short intracortical inhibition (SICI) and intracortical facilitation (ICF) will be evoked with paired-pulse TMS at various interstimulus intervals according to the methods previously employed (Murray \& Knikou, 2017).
Measured: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing spinal plasticity
Spinal plasticity will be measured via single-pulse TSCS recruitment curves (Aim 2b).
Measured: Assess change from baseline to 10 minutes after completion of drug+task training.
Tracking cardiovascular responses (heart rate)
Observed measures of heart rate (HR) (Aim 3a) will be monitored throughout.
Measured: Measured every 5-10 minutes, for up to 4 hours. Change will be compared to baseline.
Tracking cardiovascular responses (blood oxygen saturation)
Observed measures of blood oxygen saturation (SpO2) (Aim 3a) will be monitored throughout.
Measured: Measured every 5-10 minutes, for up to 4 hours. Change will be compared to baseline.
Tracking cardiovascular responses (blood pressure)
Observed measures of blood pressure (BP) (Aim 3a) will be monitored throughout.
Measured: Measured every 5-10 minutes, for up to 4 hours. Change will be compared to baseline.
Tracking symptoms
Participant-reported safety questionnaire (Aim 3b) will be monitored for any symptoms felt throughout the study.
Measured: Measured every 5-10 minutes, for up to 4 hours. Change will be compared to baseline.
Tracking side effects (drug administration)
Adverse event (AE) questionnaire (Aim 3b) related to any participant-reported experience following drug administration.
Measured: Assess change from end of day 1 testing to 24 hours after study completion.
Tracking side effects (study testing stimulation)
Adverse event (AE) questionnaire (Aim 3b) related to any participant-reported experience following brain and/or spinal stimulation received during the experiment.
Measured: Assess change from end of day 1 testing to 24 hours after study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start20 Jan 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, placebo-controlled, single-dose, randomized crossover investigation to one of four conditions: 1) CPH + hand training; 2) CD-LD + hand training; 3) ATX + hand training; and 4) placebo + hand training, performed at least a week apart. Outcomes measures will be assessed before and 60 minutes after study drug administration.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Lynda M. Murray, Bronx VA Medical Center
- Investigators
- Lynda M Murray, PhD, Principal investigator, Bronx VA Medical Center / James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708274
- Sponsor's protocol ID
- JJPVAMC IRB 1685818
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified, individual-level data will be deposited to appropriate public repositories, such as Open Data Commons for Spinal Cord Injury (https://scicrunch.org/odc-sci), Figshare, or others. This will allow more powerful meta-analysis of disparate smaller studies, a need which is even more urgent in neurorehabilitation than in other fields that are more amenable to large drug studies.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pharmacological Agents in Restoring Neuronal Excitability After Chronic Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT05708274
- Acronym / sponsor ID
- JJPVAMC IRB 1685818
- Conditions
- Spinal Cord Injuries
- Keywords
- Transcranial magnetic stimulation, Pharmacological agents, Transcutaneous spinal cord stimulation, Hand exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 1 Feb 2023 (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 purpose of this study is to investigate the short-term effects of 3 approved FDA drugs (cyproheptadine (CPH), carbidopa-levodopa (CD-LD), and atomoxetine (ATX)) on motor responses when delivered in combination with hand training exercises in people with chronic spinal cord injury. The goal is to learn how to better strengthen connections between the brain and spinal cord after spinal cord injury, and if this connection is improved by one(or more) of the drugs. Multiple aspects of nerve transmission and muscle response will be measured via noninvasive brain and spinal cord stimulation, along with motor performance (dexterity and strength).
Detailed description
Research will take place at the James J. Peters VA Medical Center (JJPVAMC), Bronx, NY. There are seven visits in total, including an initial evaluation and clinical assessment session. Each visit will last roughly 5 hours or less. We plan to enroll 28 participants with spinal cord injury over a two-year period.
The study is designed as a double-blind, placebo-controlled, single-dose, randomized crossover investigation involving four study drug visits (CPH, CD-LD, ATX, or placebo).
The same participants will partake in all four interventions in randomized order with at least 1-week washout representative of greater than 5x drug half-life; to avoid accumulative effects. To reduce potential learning effects from motor training and task-related outcome measurements, participants will partake in two motor training practice sessions prior to commencing the experiments for task familiarity.
This study will consist of electromyography (surface recordings of muscle activity), peripheral nerve stimulation, transcranial magnetic brain stimulation (TMS), and transcutaneous electrical spinal cord stimulation (TSCS), targeting the hand/arm muscles.
Though it is unlikely given the single-dose nature, participants may experience side effects following drug administration. Prior to consenting, all volunteers will undergo a comprehensive pre-screening evaluation including blood tests to ensure there are no contraindications.
Please note, there is no expectation of long-term benefit from this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Double-blind, placebo-controlled, single-dose, randomized crossover investigation to one of four conditions: 1) CPH + hand training; 2) CD-LD + hand training; 3) ATX + hand training; and 4) placebo + hand training, performed at least a week apart. Outcomes measures will be assessed before and 60 minutes after study drug administration.
| Arm | Type | Receives |
|---|---|---|
| CPH + hand training | Experimental | Drug: CPH + hand trainingA single dose of Cyproheptadine (CPH) (8 mg) will be administered. Supplied as 2 over-encapsulated pills of 4 mg each. |
| CD-LD + hand training | Experimental | Drug: CD-LD + hand trainingA single dose of IR Carbidopa-levodopa (CD-LD) (50/200 mg) will be administered. Supplied as 2 over-encapsulated pills (25 mg carbidopa / 100 mg levodopa each). |
| ATX + hand training | Experimental | Drug: ATX + hand trainingA single dose of Atomoxetine (ATX) (40 mg) will be administered. Supplied as 1 over-encapsulated pill of 40 mg plus 1 placebo capsule. |
| Placebo + hand training | Placebo comparator | Drug: Placebo + hand trainingA single dose of Placebo will be administered. Supplied as 2 gelatin capsules, identical in number, size, shape and color, filled with microcrystalline cellulose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female between 18 and 65 years of age; clinically stable chronic (> 12 months) SCI at or above C8 spinal segment;
- Motor-incomplete with a score of 2 or more (out of 5) on manual muscle testing (MMT) of finger extension, finger flexion, or finger abduction in left or right hand(s); or able to perform thumb-index finger pinch of the left or right hand;
- Detectable stimulation-evoked muscle responses of the left or right first dorsal interosseous (FDI) and/or abductor pollicis brevis (APB); Detectable FDI/APB surface electromyography (EMG) muscle activity during thumb-index finger pinch;
- Must have stable: medication [≥ 30 days prior]; rehabilitation regimen [≥ 15 days prior];
- Must be able to: abstain from alcohol, smoking and caffeine consumption on the day prior/of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 7 visits); provide informed consent.
Key exclusion criteria (16 listed)
- History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
- History of other serious central or peripheral neurological injury;
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain stimulation or task performance;
- Ventilator dependence or patent tracheostomy site;
- Unstable syrinx, or multiple spinal cord lesions;
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 |
|---|---|---|
| CPH + hand trainingFollowing a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements. | Drug | CPH + hand training |
| CD-LD + hand trainingFollowing a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements. | Drug | CD-LD + hand training |
| ATX + hand trainingFollowing a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements. | Drug | ATX + hand training |
| Placebo + hand trainingFollowing a 10-minute rest after baseline measurements a single dose pharmacological agent or placebo will be administered, in blinded fashion, with up to 180 mL of noncarbonated water, on an empty stomach (minimum 2 hours without food). After capsule ingestion, participants will spend 50 minutes performing hand task-oriented training, resting for 10 minutes before undertaking post-intervention outcome measurements. | Drug | Placebo + hand training |
Primary outcome
Assessing task performance (dexterity)
Time frame: Assess change from baseline to 10 minutes after completion of drug+task training.
Unilateral manual dexterity will be assessed using the 9-Hole Peg Test (Aim 1a).
12 secondary outcomes
Assessing task performance (dexterity)
Time frame: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing volitional grip strength
Time frame: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing volitional pinch strength
Time frame: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing corticospinal plasticity
Time frame: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing cortical plasticity
Time frame: Assess change from baseline to 10 minutes after completion of drug+task training.
Assessing spinal plasticity
Time frame: Assess change from baseline to 10 minutes after completion of drug+task training.
Tracking cardiovascular responses (heart rate)
Time frame: Measured every 5-10 minutes, for up to 4 hours. Change will be compared to baseline.
Tracking cardiovascular responses (blood oxygen saturation)
Time frame: Measured every 5-10 minutes, for up to 4 hours. Change will be compared to baseline.
Tracking cardiovascular responses (blood pressure)
Time frame: Measured every 5-10 minutes, for up to 4 hours. Change will be compared to baseline.
Tracking symptoms
Time frame: Measured every 5-10 minutes, for up to 4 hours. Change will be compared to baseline.
Tracking side effects (drug administration)
Time frame: Assess change from end of day 1 testing to 24 hours after study completion.
Tracking side effects (study testing stimulation)
Time frame: Assess change from end of day 1 testing to 24 hours after study completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. Deidentified, individual-level data will be deposited to appropriate public repositories, such as Open Data Commons for Spinal Cord Injury (https://scicrunch.org/odc-sci), Figshare, or others. This will allow more powerful meta-analysis of disparate smaller studies, a need which is even more urgent in neurorehabilitation than in other fields that are more amenable to large drug studies.
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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.
Lynda M Murray, PhD principal investigator
Bronx VA Medical Center / James J. Peters Veterans Affairs Medical Center
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 CPH + hand training, CD-LD + hand training and ATX + hand training in people with Spinal Cord Injuries, run by Bronx VA Medical Center 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 5 inclusion and 16 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 8 Dec 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessing task performance (dexterity) (time frame: Assess change from baseline to 10 minutes after completion of drug+task training.). 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 8 Dec 2025.