RECRUITING

Pharmacological Agents for Chronic Spinal Cord Injury (SCI)

Conditions

Spinal Cord Injuries Transcranial magnetic stimulation Pharmacological agents Transcutaneous spinal cord stimulation Hand exercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

The Role of Pharmacological Agents in Restoring Neuronal Excitability After Chronic Spinal Cord Injury (SCI)

Quick Facts

Study Start:2023-01-20

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05708274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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; * 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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;
* 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.

Contacts and Locations

Study Contact

Caitlyn "Sig" N Sigafose, BS

CONTACT

718-584-9000

caitlyn.sigafose@va.gov

Francisco E Castano, MPH

CONTACT

718-584-9000

francisco.castano@va.gov

Principal Investigator

Lynda M Murray, PhD

PRINCIPAL_INVESTIGATOR

Bronx VA Medical Center / James J. Peters Veterans Affairs Medical Center

Study Locations (Sites)

James J. Peters Veterans Affairs Medical Center

Bronx, New York, 10468

United States

Collaborators and Investigators

Sponsor: Bronx VA Medical Center

Lynda M Murray, PhD, PRINCIPAL_INVESTIGATOR, Bronx VA Medical Center / James J. Peters Veterans Affairs Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-20

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2023-01-20

Study Completion Date2025-07-30

Terms related to this study

Keywords Provided by Researchers

Transcranial magnetic stimulation
Pharmacological agents
Transcutaneous spinal cord stimulation
Hand exercise

Additional Relevant MeSH Terms

Spinal Cord Injuries