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PI left study institution, declined to continue study at new institution
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The study investigates the effect of using transcranial direct current stimulation (tDCS) and skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle and leg motor control in persons with ambulatory persons with spinal cord injury.
Hypotheses H1: Participants will display greater improvement in stepping function following tDCS combined with training compared to sham-tDCS and training.
H2: Participants will display greater gains in cortical excitability, as evidenced by lower cortico-motor threshold (MT) associated with the TA muscles following tDCS and training compared to following sham stimulation and training.
H3: Participants in the tDCS+training group will show greater increases walking speed in a timed 10 meter walking trial.
H4: Participants in the tDCS+training group will show be able to perform a greater number of toe-taps test.
An estimated 265,000 individuals live with the consequences of SCI in the United States alone. Individuals with motor incomplete spinal cord injury (MISCI) commonly experience loss or impairment of lower extremity function. There are a limited number of options for restoration of walking function in individuals with motor-incomplete spinal cord injury (MISCI) who exhibit some ability to stand and walk but may be impeded by impaired voluntary control of the lower limb particularly, the ankle.
In persons with spinal cord injury, walking function is often limited by poor ability to lift and advance the legs. Lower extremity orthotic devices may be employed to stabilize the ankle joint and provide toe clearance during walking. However, these devices are cumbersome, and may be aesthetically unappealing.
Newer evidence indicates that non-invasive approaches to brain stimulation may provide a way to improve voluntary control of the legs and ankles in persons with neurologic disorders.
Purpose of this research study:
The overall goal of this study is to develop functional rehabilitation strategies that facilitate optimal restoration of leg and ankle motor control in individuals with MISCI. Individuals with MISCI exhibit some motor function below the level of lesion and include American Spinal Injury Association Impairment Scale (AIS) classifications AIS C and AIS D. We propose to test non-invasive cortical stimulation in combination with lower-extremity functional motor training for its ability to assist in improving fine motor control of the lower limbs in individuals with MISCI.
Studies have shown that non-invasive transcranial direct current stimulation (tDCS) can increase activity in specific cortical areas associated with motor learning, and therefore improve on the cortical and functional effects associated with motor practice training in individuals with SCI. If brain stimulation in combination with motor training is found to enhance improvements in control more effectively than motor training alone, this would provide a basis for further examining stimulation combined with lower limb joint therapy in individuals with spinal cord injury.
Objectives: To Assess improvements in lower extremity motor control that are associated with bilateral tDCS and functional motor training or sham tDCS and functional motor training in individuals with motor incomplete spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS and skilled training | Experimental | tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training |
|
| Sham tDCS and skilled leg training | Sham Comparator | Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation + step training | Device | Direct current stimulation of motor cortex with low stimulation intensity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Midswing Ankle ROM | Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait. | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. |
| Change From Baseline Active Motor Threshold | Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Scores of a 10 m Walk Test | Change from baseline score of the time required to perform 10 m walking. | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. |
| Change From Baseline Score on Toe Tap Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edelle C Field Fote, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miami Project to Cure Paralysis | Miami | Florida | 33136 | United States |
One participant withdrew before assignment
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| ID | Title | Description |
|---|---|---|
| FG000 | Real tDCS - Sham tDCS | Real tDCS+skilled training Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity Step training: Stepping over specified soft foam obstacles Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Step training: Stepping over specified soft foam obstacles |
| FG001 | Sham tDCS - Real tDCS | Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Step training: Stepping over specified soft foam obstacles Real tDCS+skilled training Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity Step training: Stepping over specified soft foam obstacles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
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| ID | Title | Description |
|---|---|---|
| BG000 | Real tDCS - Sham tDCS | Real tDCS+skilled training Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity Step training: Stepping over specified soft foam obstacles Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Step training: Stepping over specified soft foam obstacles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 From Baseline Midswing Ankle ROM | Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait. | Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director. | Posted | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. |
|
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Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
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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 | tDCS and Skilled Training | tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edelle Field-Fote | Shepherd Center | 404-603-4274 | edelle_field-fote@shepherd.org |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham transcranial direct current stimulation + step training | Behavioral | Stepping over specified soft foam obstacles |
|
|
Measuring the Time required to perform toe taps
| Two times, 1) Baseline, and 2) Up to 1 hour after intervention. |
| BG001 | Sham tDCS - Real tDCS | Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Step training: Stepping over specified soft foam obstacles Real tDCS+skilled training Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity Step training: Stepping over specified soft foam obstacles |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Sham tDCS and Skilled Leg Training | Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles |
|
| Primary | Change From Baseline Active Motor Threshold | Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area | Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director. | Posted | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. |
|
|
| Secondary | Change From Baseline Scores of a 10 m Walk Test | Change from baseline score of the time required to perform 10 m walking. | Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director. | Posted | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. |
|
|
| Secondary | Change From Baseline Score on Toe Tap Test | Measuring the Time required to perform toe taps | Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director. | Posted | Two times, 1) Baseline, and 2) Up to 1 hour after intervention. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Sham tDCS and Skilled Leg Training | Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles | 0 | 0 | 0 | 0 |
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| D014947 | Wounds and Injuries |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |