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| Name | Class |
|---|---|
| Mission Connect a project of TIRR Foundation | UNKNOWN |
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This study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (iSCI).
Spinal Cord Injury (SCI) has been associated with serious reduction in functional independence. Despite compelling evidence that treatment intensity has a profound effect on motor recovery only a small fraction of SCI population are able to receive intensive in-clinic treatment. Difficulty traveling to the clinic, poor adherence to assignments and high cost are limiting factors. Currently, telerehabilitation programs are emerging as an alternative effective method of delivery for rehabilitation services. The literature and our preliminary findings support the model that augmentation of activity in spared corticospinal tract (CST) axons is a critical mechanism of motor improvement, and furthermore that CST activity can be increased by repetitive motor training and by electrical stimulation of the primary motor cortex (M1). However, there is still lack of knowledge on safety, feasibility and efficacy of remotely- supervised home-based therapy programs that incorporates non-invasive brain stimulation and high intensity repetitive arm exercises. To address these questions, 36 adults (above 18 years) with cervical SCI will be randomly assigned to two groups in a 2:1 ratio (active stimulation group, n=24 vs control group, n=12) and receive daily treatment, 10 sessions, over 2-weeks. The anodal tDCS will be applied over primary motor cortex (M1) at an intensity of 2mA for 20 minutes and proceed with 60 minutes of repetitive arm and hand training. Primary outcome measure is change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) from baseline to immediately after treatment and 4-weeks follow-up. The session will be supervised in real-time via videoconferencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes |
|
| Sham tDCS | Sham Comparator | Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function. | Baseline |
| Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function. | 2 weeks |
| Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence With the Therapy as Assessed by the Number of Sessions Participants Attended | Treatment Day 1- Day 10 | |
| Adherence With the Therapy as Assessed by the Number of Participant Drop-outs | Between enrollment and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuray Yozbatiran, PhD, PT | The University of Texas Health Sciences Center at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. |
| FG001 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
up to 6 weeks
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nuray Yozbatiran, PhD, PT | The University of Texas Health Sciences Center at Houston | 7137975282 | Nuray.Yozbatiran@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2022 | Mar 31, 2025 | Prot_SAP_000.pdf |
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Double-blind, randomized controlled trial
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active or sham tDCS
|
| Sham tDCS | Device | Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. |
|
| Feasibility of Home Intervention as Indicated by Participants' Perceptions of Usefulness of the Intervention as Assessed by the Visual Analog Scale (VAS) | Participants rated the usefulness of the interventions on a scale of 0 to 10, with 0 indicating not useful at all and 10 indicating very useful. | Day 10 |
| Grip Strength | Maximum force generated by hand muscles and measured with a hand-held dynamometer | Baseline |
| Grip Strength | Maximum force generated by hand muscles and measured with a hand-held dynamometer | 2 weeks |
| Grip Strength | Maximum force generated by hand muscles and measured with a hand-held dynamometer | 6 weeks |
| Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) | Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions. | Baseline |
| Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) | Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions. | 2 weeks |
| Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) | Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions. | 6 weeks |
| Number of Participants Who Had Adverse Events | from baseline to 6 weeks |
| Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using tDCS as Assessed by the Visual Analog Scale (VAS) | Participants rated the level of difficulty of using tDCS on a scale of 0 to 10, with 0 indicating not difficult at all and 10 indicating very difficult | Day 10 |
| Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using Exercise Equipment as Assessed by the Visual Analog Scale (VAS) | Participants rated the level of difficulty of using exercise equipment on a scale of 0 to 10, with 0 indicating not difficult at all and 10 indicating very difficult. | Day 10 |
| BG001 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Asia Impairment Scale Classification | The Asia Impairment Scale (AIS) categorizes spinal cord injury severity based on sensory and motor function loss. AIS Classification: A = Complete: No motor/sensory function in the sacral segments S4-S5 B = Incomplete: Sensory but not motor function below the neurological level, includes the sacral segments S4-S5 C = Incomplete: Below the neurological level, motor function preserved and more than 50% of key muscles have a muscle grade < 3 D = Incomplete: Below the neurological level, motor function persevered and at least 50% of key muscles have a muscle grade ≥3 | Count of Participants | Participants |
|
| Time Since Injury | Mean | Standard Deviation | Months |
|
| OG001 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. |
|
|
| Primary | Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Primary | Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Secondary | Adherence With the Therapy as Assessed by the Number of Sessions Participants Attended | Posted | Mean | Standard Deviation | sessions | Treatment Day 1- Day 10 |
|
|
|
| Secondary | Adherence With the Therapy as Assessed by the Number of Participant Drop-outs | Posted | Count of Participants | Participants | Between enrollment and 6 weeks |
|
|
|
| Secondary | Feasibility of Home Intervention as Indicated by Participants' Perceptions of Usefulness of the Intervention as Assessed by the Visual Analog Scale (VAS) | Participants rated the usefulness of the interventions on a scale of 0 to 10, with 0 indicating not useful at all and 10 indicating very useful. | Posted | Mean | Standard Deviation | score on a scale | Day 10 |
|
|
|
| Secondary | Grip Strength | Maximum force generated by hand muscles and measured with a hand-held dynamometer | Posted | Mean | Standard Deviation | pounds (lbs) | Baseline |
|
|
|
| Secondary | Grip Strength | Maximum force generated by hand muscles and measured with a hand-held dynamometer | Posted | Mean | Standard Deviation | pounds (lbs) | 2 weeks |
|
|
|
| Secondary | Grip Strength | Maximum force generated by hand muscles and measured with a hand-held dynamometer | Posted | Mean | Standard Deviation | pounds (lbs) | 6 weeks |
|
|
|
| Secondary | Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) | Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) | Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) | Total score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
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| Secondary | Number of Participants Who Had Adverse Events | Posted | Count of Participants | Participants | from baseline to 6 weeks |
|
|
|
| Secondary | Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using tDCS as Assessed by the Visual Analog Scale (VAS) | Participants rated the level of difficulty of using tDCS on a scale of 0 to 10, with 0 indicating not difficult at all and 10 indicating very difficult | Posted | Mean | Standard Deviation | score on a scale | Day 10 |
|
|
|
| Secondary | Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using Exercise Equipment as Assessed by the Visual Analog Scale (VAS) | Participants rated the level of difficulty of using exercise equipment on a scale of 0 to 10, with 0 indicating not difficult at all and 10 indicating very difficult. | Posted | Mean | Standard Deviation | score on a scale | Day 10 |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance. | 0 | 7 | 0 | 7 | 2 | 7 |
| Autonomic Dysreflexia (AD) | Nervous system disorders | Non-systematic Assessment |
|
| Pelvic pain on right side | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sick day during home therapy | General disorders | Non-systematic Assessment |
|
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