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This study will be performed in patients with peripheral neuropathy who are walking independently, but have complains of balance problems such as recent falls or difficulty walking and show reduced vibratory and proprioceptive sensation during routine neurologic examination. These patients will be tested for proprioceptive and vibratory threshold at the toes and ankles before, during and after receiving anodal direct transcranial cortical stimulation (dTCS) over sensory and motor cortices. Subjects will be asked to participate in 2 sessions.
This study will be performed in patients with peripheral neuropathy who are walking independently, but have complains of balance problems such as recent falls or difficulty walking and show reduced vibratory and proprioceptive sensation during routine neurologic examination. These patients will be tested for proprioceptive and vibratory threshold at the toes and ankles before, during and after receiving anodal transcranial direct current stimulation (tDCS) over sensory and motor cortices. Subjects will be asked to participate in 2 sessions. In one of the sessions, decided randomly, the stimulation will be applied on the right side and in the second session it will be on the left.
The tDCS portion of the experiment will begins with direct current (maximum of 2 mA) stimulation delivered through surface electrodes (TransQE from IOMED®, surface area: 25 cm2) using a Phoresor® II Auto (Model No. PM850, IOMED®, Salt Lake City, Utah 84120, USA). One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dTCS | Experimental | Patient will receive dTCS with direct current (maximum of 2 mA) stimulation delivered through surface electrodes (TransQE from IOMED®, surface area: 25 cm2) using a Phoresor® II Auto (Model No. PM850, IOMED®, Salt Lake City, Utah 84120, USA) or Sham stimulation. |
|
| Sham | Sham Comparator | Patients will receive a sham. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dTCS | Device | Direct current (DC) (maximum of 2 mA) stimulation delivered through surface electrodes. One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes | Vibration is measured by reading in Rydel Seiffer tuning fork that ranges between 0-8 and is a standard tool fro measuring vibration sensation at the toes. A reading of 0 means absent vibration. A reading of more than 4 at the toes are considered normal. Change between assessment at 20 minutes and 10 minutes at the toes will be assessed. A recording of less than 4 indicates an abnormal results and a lower number means worse neuropathy. For example, reading of 0 means absent vibration feeling which indicates worse neuropathy than a reading of 2. | At 10 and 20 minutes |
| Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe | At 10 and 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Khoshnoodi, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | dTCS | patients received dTCS |
| FG001 | Sham | Subjects received Sham stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | dTCS | Patients received dTCS |
| BG001 | Sham | Subjects received Sham stimulation |
| 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 | Change in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes | Vibration is measured by reading in Rydel Seiffer tuning fork that ranges between 0-8 and is a standard tool fro measuring vibration sensation at the toes. A reading of 0 means absent vibration. A reading of more than 4 at the toes are considered normal. Change between assessment at 20 minutes and 10 minutes at the toes will be assessed. A recording of less than 4 indicates an abnormal results and a lower number means worse neuropathy. For example, reading of 0 means absent vibration feeling which indicates worse neuropathy than a reading of 2. | Due to lack of participation for sham group, data for outcome measures in sham group was not collected. | Posted | Mean | Standard Deviation | units on a scale | At 10 and 20 minutes |
|
1 week
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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 | dTCS | patients received dTCS | 0 |
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Low number of subjects prevented statistical analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Khoshnoodi | Johns Hopkins University | 410-955-5460 | mkhoshn1@jhmi.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 1, 2020 | May 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Sham device | Device | The device will administer a sham. |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sham | Subjects received Sham stimulation |
|
|
| Primary | Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe | Not enough patients were enrolled to reach the needed threshold to assess this outcome measure. Therefore, data was not collected. | Posted | At 10 and 20 minutes |
|
|
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Sham | Subjects received Sham stimulation | 0 | 2 | 0 | 2 | 0 | 2 |
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