Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy

Effect of Transcranial Direct Current Stimulation on Proprioceptive and Vibratory Sensation: Potential Benefit for Patients With Peripheral Neuropathy

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Device: dTCS; Device: Sham device

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dTCS; 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.	Device: 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 Comparator: Sham; Patients will receive a sham.	Device: Sham device; The device will administer a sham.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Mohammad Khoshnoodi, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: IRB00066426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO