Combined Hypoxia Therapy and Rehabilitation for Spinal Cord Injury

(HANDS Trial)

Recruiting at 2 trial locations

Overseen By william z rymer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Antispasticity medications

Disqualifiers: Heart failure, Hypertension, Diabetes, COPD, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

121 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall objective of this project is to investigate the effectiveness of daily acute intermittent hypoxia therapy (dAIH), coupled with massed practice training, to improve upper-extremity function in individuals with chronic incomplete cervical SCI.

Will I have to stop taking my current medications?

The trial requires participants to stop taking antispasticity medications if they wean off them to complete the screening session. They must refrain from these medications for the duration of the study.

What data supports the effectiveness of this treatment for spinal cord injury?

Research shows that acute intermittent hypoxia (AIH), which involves brief periods of low-oxygen breathing, can improve hand function and walking ability in people with spinal cord injuries. Studies in both humans and animal models suggest that AIH may help the nervous system recover and improve breathing and movement after injury. ^{1 2 3 4 5}

Is combined hypoxia therapy generally safe for humans?

Research on acute intermittent hypoxia (AIH) in humans with spinal cord injuries suggests it is generally safe, as studies have shown improvements in hand strength and breathing function without significant safety concerns. However, more studies are needed to determine the optimal dosage and long-term safety. ^{1 2 5 6 7}

How does the treatment of acute intermittent hypoxia and rehabilitation differ from other treatments for spinal cord injury?

This treatment is unique because it combines acute intermittent hypoxia (breathing low oxygen levels for short periods) with rehabilitation exercises to promote neuroplasticity (the brain's ability to reorganize itself) and improve motor function in spinal cord injury patients, which is not a standard approach in existing treatments. ^{1 2 4 5 7}

Eligibility Criteria

This trial is for adults aged 18-75 with chronic incomplete cervical spinal cord injury, at least six months post-injury. It's open to those who've had no symptom regression for two years and can show some hand muscle control. Pregnant or nursing women and individuals with certain cardiovascular, respiratory, or metabolic conditions are excluded.

Inclusion Criteria

Ability to understand and the willingness to sign an informed consent.

My elbow strength improved by at least 10% after a special breathing test.

I can voluntarily move my hand muscles and can perform at least one type of grasp.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo daily acute intermittent hypoxia therapy (dAIH) combined with massed practice training to improve upper-extremity function

3 months

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acute Intermitted Hypoxia
• Massed Practise
• Rapael Glove

Trial Overview The study tests the combination of daily acute intermittent hypoxia therapy (dAIH) and massed practice training on improving hand function. Participants will also use a Rapael Glove—a smart rehabilitation device—to aid recovery.

Participant Groups

Group I: Rapael glove with dAIH Experimental Treatment 2 Interventions

The Rapael Smart Glove is a virtual reality hand exoskeleton rehabilitation device. The tasks selected will address gross movement, hand function, and dexterity. Tasks utilized will include, but are not limited to: fly swat, throwing darts, squeezing an orange, catching a baseball, and floating fish. The number of total repetitions and activity outcomes will be recorded. Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.

Group II: Massed practice training with dAIH Experimental Treatment 2 Interventions

Seek to address gross upper extremity movements, grip and pinch strength, and coordination.The ultimate goal of the session is to achieve a total of 300 repetitions during training. Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.

Group III: Massed practice training with Sham dAIH Experimental Treatment 2 Interventions

Seek to address gross upper extremity movements, grip and pinch strength, and coordination.The ultimate goal of the session is to achieve a total of 300 repetitions during training. Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.

Group IV: Rapael glove with Sham dAIH Active Control 2 Interventions

The Rapael Smart Glove is a virtual reality hand exoskeleton rehabilitation device. The tasks selected will address gross movement, hand function, and dexterity. Tasks utilized will include, but are not limited to: fly swat, throwing darts, squeezing an orange, catching a baseball, and floating fish. The number of total repetitions and activity outcomes will be recorded. Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.

Group V: No training with dAIH Placebo Group 1 Intervention

Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%. Hearth rate and pulse oximetry will be continuously monitored throughout, and recording will be taken at each alteration in sequence. Blood pressure will be taken upon completion of the total sequence

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Findings from Research

Daily acute intermittent hypoxia (AIH) combined with hand opening practice significantly improved hand dexterity and function in all six participants with chronic cervical spinal cord injury, as evidenced by better scores on the Box and Block Test and reduced times on the Jebsen-Taylor Hand Function Test.

The study suggests that AIH may enhance the effectiveness of rehabilitation by promoting neural plasticity, but further research is needed to determine the optimal dosage, safety, and long-term effects of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Trumbower, RD., Hayes, HB., Mitchell, GS., et al.[2022]

Acute intermittent hypoxia has shown promise as a therapeutic strategy to improve respiratory function in individuals with cervical spinal cord injuries, based on studies that demonstrate its potential to induce neuroplasticity and functional recovery.

Research in animal models has laid the groundwork for exploring the effects of acute intermittent hypoxia in human clinical studies, highlighting its potential to restore breathing function after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent hypoxia and respiratory recovery in pre-clinical rodent models of incomplete cervical spinal cord injury. Gonzalez-Rothi, EJ., Lee, KZ.[2021]

This clinical trial will investigate the effects of daily acute intermittent hypoxia (AIH) on walking recovery in 85 participants with sub-acute spinal cord injury (SCI), aiming to determine if AIH can enhance recovery when combined with walking practice.

The study will assess various outcomes, including walking speed and endurance, while also monitoring safety measures like pain and spasticity, to evaluate the potential of AIH as a treatment to improve mobility in individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol. Naidu, A., Peters, DM., Tan, AQ., et al.[2020]

Acute intermittent hypoxia (AIH) is a safe and effective therapy that can enhance strength, walking speed, endurance, and dynamic balance in individuals with chronic, incomplete spinal cord injury (SCI).

AIH shows promise for promoting walking recovery through neuroplasticity mechanisms, but more research is needed to determine its effectiveness across larger groups and to identify optimal treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute intermittent hypoxia as a potential adjuvant to improve walking following spinal cord injury: evidence, challenges, and future directions. Tan, AQ., Barth, S., Trumbower, RD.[2022]

The study involved 35 participants with incomplete spinal cord injury, testing the effects of combined intermittent hypoxia and body weight-supported treadmill training over 4 weeks.

Results showed that while standing balance did not improve significantly, participants receiving intermittent hypoxia demonstrated significantly faster dynamic balance measures, indicating potential benefits for mobility in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Hypoxia and Locomotor Training Enhances Dynamic but Not Standing Balance in Patients With Incomplete Spinal Cord Injury. Navarrete-Opazo, A., Alcayaga, JJ., Sepúlveda, O., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intermittent hypoxia and respiratory recovery in pre-clinical rodent models of incomplete cervical spinal cord injury. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Acute intermittent hypoxia as a potential adjuvant to improve walking following spinal cord injury: evidence, challenges, and future directions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intermittent Hypoxia and Locomotor Training Enhances Dynamic but Not Standing Balance in Patients With Incomplete Spinal Cord Injury. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and time course of acute intermittent hypoxia effects in the upper extremities of people with cervical spinal cord injury. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intermittent Hypoxia Induces Greater Functional Breathing Motor Recovery as a Fixed Rather Than Varied Duration Treatment after Cervical Spinal Cord Injury in Rats. [2023]