← Back to Search

AIH for Spinal Cord Injury

Phase < 1
Recruiting
Led By Martin Oudega, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to complete precision and power grips
Male and females Veterans between 18-85 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week
Awards & highlights

Study Summary

This trial looks at a new way to help people with spinal cord injuries improve their arm and hand function.

Who is the study for?
This trial is for adults aged 18-85 with chronic cervical spinal cord injury (cSCI) at least a year old, who can perform certain hand grips and have some sensory function in specific areas. It's not for those with severe heart conditions, uncontrolled medical issues, major depression or psychosis, history of head injury or stroke, metal plates in the skull, seizure history, CNS-affecting drugs use, pregnancy or ongoing spinal complications.Check my eligibility
What is being tested?
The study tests whether combining acute intermittent hypoxia (rAIH) with motor training enhances upper limb function recovery after cSCI. Using an adult rat model first to inform human trials later on. Participants will undergo rAIH and exercise training versus sham treatments to compare effects on motor skills.See study design
What are the potential side effects?
Potential side effects may include discomfort from hypoxia exposure such as shortness of breath or lightheadedness during sessions; exercise-related muscle soreness; and risks associated with D-cycloserine if used in humans could involve allergic reactions or neurological changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can firmly grasp and hold objects.
Select...
I am a veteran aged between 18 and 85.
Select...
I am a Veteran aged between 18 and 85.
Select...
I have a lung condition like COPD.
Select...
I have had a spinal cord injury for over a year.
Select...
I have had a spinal cord injury for over a year.
Select...
My spinal cord injury is at the neck level, C8 or higher.
Select...
I am between 18 and 80 years old.
Select...
My hands function well enough to do training and tests.
Select...
I can pick up small objects and pinch them between my thumb and index finger.
Select...
I can firmly grasp and hold objects.
Select...
I can pick up small objects and pinch them between my thumb and index finger.
Select...
My spinal injury is at the neck level or higher.
Select...
I have had a heart attack or severe chest pain in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in grip strength
Change in motor evoked potential size
Change in pinch strength

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: hypoxia plus training plus NMDA agonistExperimental Treatment3 Interventions
combined hypoxia treatment with exercise training and with NMDA agonist treatment
Group II: hypoxia plus trainingExperimental Treatment2 Interventions
combined hypoxia treatment with exercise training
Group III: sham hypoxia plus trainingPlacebo Group2 Interventions
combined sham hypoxia treatment with exercise training
Group IV: hypoxia plus training plus sham NMDA agonistPlacebo Group3 Interventions
combined hypoxia treatment with exercise training and with sham NMDA agonist treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hypoxia
2018
N/A
~120
D-cycloserine
2013
Completed Phase 4
~1060
exercise training
2012
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,915 Total Patients Enrolled
Martin Oudega, PhDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
1 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

D-cycloserine Clinical Trial Eligibility Overview. Trial Name: NCT03780829 — Phase < 1
Spinal Cord Injury Research Study Groups: hypoxia plus training, hypoxia plus training plus NMDA agonist, sham hypoxia plus training, hypoxia plus training plus sham NMDA agonist
Spinal Cord Injury Clinical Trial 2023: D-cycloserine Highlights & Side Effects. Trial Name: NCT03780829 — Phase < 1
D-cycloserine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03780829 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still slots available for participation in this research endeavor?

"Affirmative, clinicaltrials.gov has evidence that this medical study is in the process of recruiting patients. It was published on February 25th 2020 and last modified approximately 2 years later. A total of 175 participants are required from a single centre for enrollment."

Answered by AI

Are there any past experiments involving hypoxia?

"Presently, 9 investigations into hypoxia are being conducted with 2 of them in the Phase 3 phase. Of those trials, 23 different medical institutes across the United States are involved. Notably, Baltimore Maryland is hosting a number of these ongoing studies."

Answered by AI

What health ailments does hypoxia typically address?

"Hypoxia is often used to address failed conventional therapy. Additionally, this treatment can be beneficial for those with inadequate response to traditional therapies, tuberculosis of both the pulmonary and extrapulmonary variety."

Answered by AI

Do I meet the criteria to enroll in this clinical trial?

"This medical trial is seeking 175 recruits from the age of 18 to 80. Candidates must have sci and satisfy certain neurological, motor, and sensory criteria as established by the International Standards for Neurological Classification of Spinal cord injury (ISNCSCI). Participants need to be able to complete precision and power grips with one hand, possess a visible precision grasp between their index finger and thumb, exhibit impaired but not absent or intact innervations in dermatomes C6-C8 during light touch/pin prick stimulus tests. Additionally, they must be right handed Veterans who are male or female. These requirements were put in place so that any"

Answered by AI

Does this research project admit individuals over the age of 35?

"As outlined in the inclusion criteria, individuals between 18 and 80 years old are welcome to apply for this trial. Furthermore, there is a dedicated version of the study designed specifically for minors aged under 18 as well as 8 trials geared towards people 65 or above."

Answered by AI

What is the maximum capacity for enrolment in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this investigation, which was first posted on February 25th 2020, is currently enlisting participants. A total of 175 individuals are needed to be recruited from a single medical centre."

Answered by AI
~15 spots leftby Feb 2025