Peripheral Neuropathy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEdTCS
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.
DEVICESham device
The device will administer a sham.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Peripheral Neuropathy * Walking independently but with problems with balance
Exclusion criteria
* Prominent weakness at the ankle * Not able to walk independently * History of Seizure * Cardiac Pacemaker * Metal implants in the head * Increased intracranial pressure * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes | At 10 and 20 minutes | 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. |
| Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe | At 10 and 20 minutes | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| dTCS Patients received dTCS | 2 |
| Sham Subjects received Sham stimulation | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Sham | Total | dTCS |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 1.6 | 65 years STANDARD_DEVIATION 1.78 | 63 years STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe
Time frame: At 10 and 20 minutes
Population: Not enough patients were enrolled to reach the needed threshold to assess this outcome measure. Therefore, data was not collected.
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.
Time frame: At 10 and 20 minutes
Population: Due to lack of participation for sham group, data for outcome measures in sham group was not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| dTCS | Change in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes | 0 units on a scale | Standard Deviation 0 |