Effect of Transcranial Direct Current Stimulation on Sensory Integration

Effect of Transcranial Direct Current Stimulation on Sensory Integration and Risk of Falling in Diabetic Polyneuropathy

To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.

Study Overview

• Status: Unknown
• Conditions: Diabetic Polyneuropathy
• Intervention / Treatment: Device: transcranial direct current stimulation and traditional physical therapy program; Other: designed physical therapy program

Detailed Description

PURPOSE:

To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.

BACKGROUND:

Diabetic polyneuropathy is the most prevalent chronic complication affecting 30% - 50% of diabetic patients. Diabetic polyneuropathy usually affect the peripheral, autonomic, and central nervous systems with several clinical symptoms .About 80% of the cases of DN manifest as distal symmetrical sensorimotor polyneuropathy which is responsible for cases of chronic pain; impaired sleep quality; increase of the falling risk associated with weakness and increase of the risk of extremities amputation. Transcranial direct current stimulation is neurophysiologic intervention that alters cortical excitability to enhance lower extremity somato-sensation and thus improve functional outcomes.

HYPOTHESES:

There will be no effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1 - Patient will be diagnosed as having Diabetic Polyneuropathy (DPN) and all patients have type II diabetes.

2-The age of the patients ranged from 35 to 55 years.

3-Clinically all patients suffered from glove stock hyposthesia, numbness and burning sensation and mild distal moror weakness

4-Patients have sensorymotor peripheral neuropathy according to neurophysiological study to detect sensory and motor conduction velocity to confirm diagnosis.

Exclusion Criteria:

1. History of diabetic ulcer and amputation .
2. Osteoporosis.
3. Fractures of lower limbs.
4. Gross musculoskeletal problems eg:burn.
5. Significant Scar tissue or calluses on the feet.
6. Peripheral vascular diseases (PVD) or Microcirculation problems.
7. Balance disturbance rather than diabetic peripheral neuropathy as ear problems, labrynthinitis, stroke or cerebellar problems.
8. Visual disturbance.
9. Autonomic neuropathy.
10. Advanced Osteoarthritis of lower limbs.
11. Nerve root compression (Radicuolopathy) affecting lower limbs.
12. Patients with implanted devices for pain control such as deep brain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial direct current stimulation; Transcranial direct current stimulation will be applied to study group only . Anodal transcranial stimulation will be applied on left somatosensory cortex while the cathodal one will be applied on right supra-orbital area with frequency of 2m.A for 20 minutes.Stimulation will be applied three times per week for two months.	Device: transcranial direct current stimulation and traditional physical therapy program; Transcranial stimulation will be applied only for the study group.; Other Names: Gymna- uniphy(phy-action 787); Other: designed physical therapy program; sensory training and balance training
Placebo Comparator: traditional physical therapy program; traditional physical therapy program will be applied to both the control group and study group. It will be consist of sensory re-education training and balance training.Exercises will be applied three times per week for two months	Other: designed physical therapy program; sensory training and balance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sway index of sensory integration test	sway index of sensory integration test will be measured by biodex balance system	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk of fall index	risk of fall index will be measured by biodex balance system	two months

Collaborators and Investigators

• Sponsor: MTI University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies
• Other Study ID Numbers: P.T.REC/012/002000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No