Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients

heba ahmed khalifa

Status: Active, not recruiting

Conditions: Diabetic Peripheral Neuropathy

Treatments: Device: Vagus nerve stimulation; Other: A computer based cognitive rehabilitation program (Rehacom system)

Study type: Interventional

Funder types: Other

Identifiers

NCT06048653

P.T.REC/012/003942

Details and patient eligibility

About

Diabetic peripheral neuropathy (DPN) occurs due to long standing hyperglycemia and associated metabolic derangements. Cognitive impairment is a common complication in diabetes mellitus. It is associated with a faster rate of cognitive decline.

Full description

This research aims to

• determine the effect of non-invasive Vagus nerve stimulation on cognitive functions in diabetic peripheral neuropathy.
• investigate the correlation between cognitive function and severity of diabetic neuropathy.
• investigate the correlation between cognitive function and quality of life in diabetic peripheral neuropathy.

Enrollment: 40 patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with diabetic polyneuropathy
• Female patients.
• age ranges from 40 to 55 years old.
• Duration of diabetic illness started since at least three years.
• Patients with mild to moderate neuropathy according to Toronto clinical neuropathy score
• Patients with cognitive function ranges from 24 - 15 score according to Mini mental state examination
• Patients with HbA1c ranges from seven to nine score.
• Ambulant patients with or without walking aids.
• Medically and psychologically stable patients without cardiac problems, confirmed by Electro Cardiogram (ECG).
• able to understand instructions.

Exclusion criteria

• Type I diabetes mellitus.
• Severe visual, verbal or acoustic impairments.
• Sever cognitive dysfunctions or that caused by other cause rather than diabetes mellitus.
• Polyneuropathy caused by other cause rather than diabetes mellitus.
• Other neurological problem as stroke.
• Cardiovascular problems.
• Metallic implants
• Illiterate patients.
• Uncooperative patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

control group

Experimental group

Description:

The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system)

Treatment:

Other: A computer based cognitive rehabilitation program (Rehacom system)

study group

Experimental group

Description:

The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation.

Treatment:

Other: A computer based cognitive rehabilitation program (Rehacom system)

Device: Vagus nerve stimulation