Effect of Transcranial Direct Current Stimulation on Sensory Integration

• Sponsor: MTI University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04516200
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Polyneuropathy	Device: transcranial direct current stimulation and traditional physical therapy program; Other: designed physical therapy program	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group 1: transcranial direct current stimulation and traditional physical therapy program Group 2: the same traditional physical therapy programGroup 1: transcranial direct current stimulation and traditional physical therapy program Group 2: the same traditional physical therapy program
• Masking: Single (Participant)
• Masking Description: single blind masking
• Primary Purpose: Treatment
• Official Title: Effect of Transcranial Direct Current Stimulation on Sensory Integration and Risk of Falling in Diabetic Polyneuropathy
• Anticipated Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: Oct 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. sway index of sensory integration test [two months]

   sway index of sensory integration test will be measured by biodex balance system

Secondary Outcome Measures

1. risk of fall index [two months]

   risk of fall index will be measured by biodex balance system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• MTI University

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Jul 15, 2018

More Information

Publications

None provided.

• Responsible Party: Sara Salah El-Din Abdel Megeed, principal investigator, MTI University
• ClinicalTrials.gov Identifier: NCT04516200
• Other Study ID Numbers: P.T.REC/012/002000
• First Posted: Aug 18, 2020
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polyneuropathies; Diabetic Neuropathies

Study Results

No Results Posted as of Aug 20, 2020