Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy

Johns Hopkins University

Status: Terminated

Conditions: Peripheral Neuropathy

Treatments: Device: dTCS; Device: Sham device

Study type: Interventional

Funder types: Other

Identifiers

NCT03073759

IRB00066426

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

4 participants in 2 patient groups

dTCS

Experimental 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.

Treatment:

Device: dTCS

Sham

Sham Comparator group

Description:

Patients will receive a sham.

Treatment:

Device: Sham device