Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03073759
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy	Device: dTCS; Device: Sham device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Transcranial Direct Current Stimulation on Proprioceptive and Vibratory Sensation: Potential Benefit for Patients With Peripheral Neuropathy
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe [At 10 and 20 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 1, 2020

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03073759
• Other Study ID Numbers: IRB00066426
• First Posted: Mar 8, 2017
• Last Update Posted: Aug 17, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Peripheral Nervous System Diseases

Study Results

Participant Flow

Arm/Group Title	dTCS	Sham
Arm/Group Description	patients received dTCS	Subjects received Sham stimulation
Period Title: Overall Study
STARTED	2	2
COMPLETED	2	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	dTCS	Sham	Total
Arm/Group Description	Patients received dTCS	Subjects received Sham stimulation	Total of all reporting groups
Overall Participants	2	2	4
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (2)	67 (1.6)	65 (1.78)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 50%	1 25%
Male	2 100%	1 50%	3 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	2 100%	2 100%	4 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	dTCS	Sham
Arm/Group Description	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.	Subjects received Sham stimulation
Measure Participants	2	0
Mean (Standard Deviation) [units on a scale]	0 (0)

2. Primary Outcome

Title	Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe
Time Frame	At 10 and 20 minutes

Outcome Measure Data

Analysis Population Description

Not enough patients were enrolled to reach the needed threshold to assess this outcome measure. Therefore, data was not collected.

Arm/Group Title	dTCS	Sham
Arm/Group Description	patients received dTCS	Subjects received Sham stimulation
Measure Participants	0	0

Adverse Events

Time Frame	1 week
Arm/Group Title	dTCS		Sham
Arm/Group Description	patients received dTCS		Subjects received Sham stimulation
All Cause Mortality
	dTCS		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Serious Adverse Events
	dTCS		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	dTCS		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)

Limitations/Caveats

Low number of subjects prevented statistical analysis.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.