Combined Effects of Transcranial Direct Current Stimulation on Postural Control in Elderly

NCT ID: NCT06757088

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-02-15

Brief Summary

The current study aims to determine the effects of combination stimulation (M1 Cortex+ Cerebellum) along with balance training (X-box with Kinect) on postural control in elderly population and to compare the combined stimulation (M1+CbS) with individual motor cortex, cerebellar or sham stimulation.

Detailed Description

The current study has been designed to investigate the potential effects of short term transcranial direct current stimulation on motor cortex and cerebellum both simultaneously and to document any additional benefits over each individual stimulations (M1 cortex stimulation, cerebellar stimulation or sham stimulation). Patients will be receiving the transcranial direct current stimulation combined with non-immersive virtual reality using Xbox 360 with Kinect in each group.

Conditions

Postural; Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

M1 Stimulation Group (MSG)

For M1, the anodal electrode will be placed over M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region.

Group Type: ACTIVE_COMPARATOR

M1 Stimulation Group

Intervention Type: DEVICE

For M1, the anodal electrode will be placed over M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region.

Cerebellar Stimulation Group (CbSG)

For the CbSG, active anodal electrode will be placed over the cerebellum bilaterally about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode will be placed on right buccinator muscle

Group Type: OTHER

Cerebellar Stimulation Group (CbSG)

Intervention Type: DEVICE

For the Cerebellar Stimulation Group, active anodal electrode will be placed over the cerebellum bilaterally about 1-2 cm below the inion occipital protuberance, whereas the returning cathodal electrode will be placed on right buccinator muscle

M1 + cerebellar stimulation group

In M1, the anodal electrode will be placed over the M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region whereas simultaneously for the CbSG, active anodal electrode will be placed over the cerebellum bilaterally about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode will be placed on right buccinator muscle

Group Type: EXPERIMENTAL

M1 + Cerebellar Stimulation Group

Intervention Type: COMBINATION_PRODUCT

In M1, the anodal electrode will be placed over the M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region whereas simultaneously for the CbSG, active anodal electrode will be placed over the cerebellum bilaterally about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode will be placed on right buccinator muscle.

Sham Stimulation group (SSG)

In Sham stimulation, Electrodes will be placed according to M1 Stimulation i.e., the anodal electrode will be placed over M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region.

Group Type: SHAM_COMPARATOR

Sham Stimulation Group

Intervention Type: DEVICE

In Sham stimulation, Electrodes will be placed according to M1 Stimulation i.e., the anodal electrode will be placed over M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region.

Interventions

M1 Stimulation Group

For M1, the anodal electrode will be placed over M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region.

Intervention Type: DEVICE

Cerebellar Stimulation Group (CbSG)

For the Cerebellar Stimulation Group, active anodal electrode will be placed over the cerebellum bilaterally about 1-2 cm below the inion occipital protuberance, whereas the returning cathodal electrode will be placed on right buccinator muscle

Intervention Type: DEVICE

M1 + Cerebellar Stimulation Group

In M1, the anodal electrode will be placed over the M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region whereas simultaneously for the CbSG, active anodal electrode will be placed over the cerebellum bilaterally about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode will be placed on right buccinator muscle.

Intervention Type: COMBINATION_PRODUCT

Sham Stimulation Group

In Sham stimulation, Electrodes will be placed according to M1 Stimulation i.e., the anodal electrode will be placed over M1 region while the cathodal electrode will be placed over the right contralateral supraorbital region.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Both genders
• Healthy elderly patients
• Age group of ≥ 60 years
• Fluent in reading and speaking Urdu language

Exclusion Criteria

• Patients who have any congenital/Acquired walking or standing difficulty due to certain circumstances won't be included in the healthy adults group.
• Patients with Osteo-Arthritis (OA)
• Patients with cerebellar issues or issues such as vertigo with standing and walking etc.
• Individuals who had significant dysarthria or aphasia that might impair understanding of speech or verbal instruction
• Cognitive/communication impairment

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arshad Nawaz Malik

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Summaiya Ishtiaq/01899

Identifier Type: -

Identifier Source: org_study_id