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Trial Outcomes & Findings for Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy (NCT NCT03073759)

NCT ID: NCT03073759

Last Updated: 2020-08-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

At 10 and 20 minutes

Results posted on

2020-08-17

Participant Flow

Participant milestones

Participant milestones
Measure
dTCS
patients received dTCS
Sham
Subjects received Sham stimulation
Overall Study
STARTED
2
2
Overall Study
COMPLETED
2
2
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
dTCS
n=2 Participants
Patients received dTCS
Sham
n=2 Participants
Subjects received Sham stimulation
Total
n=4 Participants
Total of all reporting groups
Age, Continuous
63 years
STANDARD_DEVIATION 2 • n=5 Participants
67 years
STANDARD_DEVIATION 1.6 • n=7 Participants
65 years
STANDARD_DEVIATION 1.78 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: At 10 and 20 minutes

Population: Due to lack of participation for sham group, data for outcome measures in sham group was not collected.

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.

Outcome measures

Outcome measures
Measure
dTCS
n=2 Participants
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. dTCS: 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.
Sham
Subjects received Sham stimulation
Change in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes
0 units on a scale
Standard Deviation 0
—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

dTCS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mohammad Khoshnoodi

Johns Hopkins University

Phone: 410-955-5460

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place