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No funding or personnel for project. We are unable to meet the recruitment goals for this pilot study.
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The purpose of this study is to test the efficacy of mild breathing bouts of low oxygen (intermittent hypoxia) combined with transcutaneous electrical spinal cord stimulation on restoring hand function in persons with chronic incomplete spinal cord injury.
The goal of this study is to determine the effectiveness of repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined with non-invasive transcutaneous electrical spinal cord stimulation (TESS) on restoring hand function in persons with chronic incomplete SCI.
The fundamental hypothesis guiding this proposal is that daily AIH+TESS engage excitatory and inhibitory pathways, which converge on a common plasticity-promoting cascade that induces greater recovery of hand function than either one alone.
Both treatments appear to enhance motor function in persons with cervical SCI. Despite their independent effects on promoting functional benefits, it is not yet know if they may promote greater functional benefits when combined. To be effective as a long-term rehabilitation strategy, it is essential to determine the efficacy of combined protocols of recurring AIH+TESS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First | Experimental | Round 1 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 1 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM. Round 2 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH. |
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| Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First | Experimental | Round 1 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM. Round 1 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH. Washout (1 month) Round 2 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIH - Intermittent Hypoxia - hypoxia air mixture | Other | Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.10±0.02 (hypoxia). Participants will receive treatment 4 times per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Extremity Function | Change compared to baseline in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: -188 to 188. Higher values represent a better outcome. | Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8) |
| Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand | Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces. | Once each intervention week (days 5, 10, and 15), and once at followup (week 8) |
| Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand | Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces. | Once each intervention week (days 5, 10, and 15), and once at followup (week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randy Trumbower, PT, PhD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28972191 | Background | Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29. | |
| 29877852 | Background | Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339. |
| Label | URL |
|---|---|
| INSPIRE Lab - dedicated to inspire persons with paralysis to move again | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First | Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
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| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2022 |
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| SHAM - Intermittent Room Air - room air mixture | Other | Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.21±0.02 (normoxia). Participants will receive treatment 4 times per week. |
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| TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice | Device | Participants will receive transcutaneous electrical stimulation to the cervical spinal cord using the TESCoN device developed by SpineX, Inc. Training will consist of progressive functional task practice for upper extremity motor training. A total of 24 treatment sessions, which will last 45 minutes per session, will be completed in 3 weeks (4 days/week) per crossover arm. |
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| 24244094 | Background | Hoffman L, Field-Fote E. Effects of practice combined with somatosensory or motor stimulation on hand function in persons with spinal cord injury. Top Spinal Cord Inj Rehabil. 2013 Fall;19(4):288-99. doi: 10.1310/sci1904-288. |
| 29649928 | Background | Gad P, Lee S, Terrafranca N, Zhong H, Turner A, Gerasimenko Y, Edgerton VR. Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. J Neurotrauma. 2018 Sep 15;35(18):2145-2158. doi: 10.1089/neu.2017.5461. |
| FG001 | Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First | Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First | Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). |
| BG001 | Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First | Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Upper Extremity Function | Upper extremity function performance metrics assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: 0 to 188. Higher values represent a better outcome. | Mean | Full Range | units on a scale |
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| Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand | Upper extremity strength assessed using dynamometers to measure grip forces. | Mean | Full Range | kg |
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| Upper Extremity Strength - Cylindrical Grip - More Impaired Hand | Upper extremity strength assessed using dynamometers to measure grip forces. | Mean | Full Range | kg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Upper Extremity Function | Change compared to baseline in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: -188 to 188. Higher values represent a better outcome. | 1 subject from SHAM+TESS First group dropped out after round 2 day 5. | Posted | Mean | Full Range | score on a scale | Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8) |
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| Primary | Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand | Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces. | 1 subject from SHAM+TESS First group dropped out after round 2 day 5. | Posted | Mean | Full Range | kg | Once each intervention week (days 5, 10, and 15), and once at followup (week 8) |
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| Primary | Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand | Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces. | 1 subject from SHAM+TESS First group dropped out after round 2 day 5. | Posted | Mean | Full Range | kg | Once each intervention week (days 5, 10, and 15), and once at followup (week 8) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 1 | Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 2 | Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round1 | Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round2 | Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). | 0 | 2 | 0 | 2 | 1 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Pressure ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
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| Dr. Randy Trumbower | Spaulding Rehabilitation | 6179526822 | randy.trumbower@mgh.harvard.edu |
| Oct 18, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First |
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). |
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| Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First |
Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Round 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). |
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