Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy

NCT03073759 | Terminated Results

• 1 other identifier: IRB00066426
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Device: dTCS

Sham

SHAM COMPARATOR

Patients will receive a sham.

Device: Sham device

Interventions

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.

dTCS

Sham device DEVICE

The device will administer a sham.

Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peripheral Neuropathy
• Walking independently but with problems with balance

You may not qualify if:

• Prominent weakness at the ankle
• Not able to walk independently
• History of Seizure
• Cardiac Pacemaker
• Metal implants in the head
• Increased intracranial pressure
• Pregnancy

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

Low number of subjects prevented statistical analysis.

Results Point of Contact

• Title: Mohammad Khoshnoodi
• Organization: Johns Hopkins University

mkhoshn1@jhmi.edu

410-955-5460

Study Officials

• Mohammad Khoshnoodi, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: March 8, 2017
• Study Start: March 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 17, 2020
• Results First Posted: August 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)