Single Session of Anodal Cerebellar vs Cerebral Transcranial Direct Current Stimulation in Stroke Patients

NCT ID: NCT05129683

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2022-09-30

Brief Summary

To compare the effect of anodal cerebellar transcranial direct current stimulation (ctDCS) vs anodal cerebral direct current stimulation on balance, mobility and cognition in stroke patients in stroke patients

Conditions

Stroke

Study Design

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

Study Groups

Anodal tDCS cerebellar stimulation group:

Anodal tDCS cerebellar stimulation

Group Type: EXPERIMENTAL

Anodal tDCS cerebellar stimulation group

Intervention Type: OTHER

Single-session atDCS (2 mA, 20 min). The active (anode) and the returning (cathode) electrodes will be placed bilaterally over the cerebellum (1 -2 cm below inion of occipital bone) and the right buccinator muscle, respectively Xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins will also be given

Anodal tDCS cerebral (M1) stimulation group:

Anodal tDCS cerebral (M1) stimulation

Group Type: EXPERIMENTAL

Anodal tDCS cerebral (M1) stimulation group

Intervention Type: OTHER

single session a-tDCS (2 mA, 20 min), the anode will be positioned over the lesioned M1 (C3, International 10-20 system) and the cathode would be located over the supraorbital area. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.

Sham Group

Sham: Single-session a-tDCS (2 mA, 20 min),

Group Type: SHAM_COMPARATOR

sham group

Intervention Type: OTHER

single session a-tDCS (2 mA, 20 min), Sham tDCS followed a similar protocol as Anodal tDCS cerebral (M1) stimulation and arrangement but stimulation for 30 s, after which the current was ramped-down and turned off for the rest of the treatment. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.

Interventions

Anodal tDCS cerebellar stimulation group

Single-session atDCS (2 mA, 20 min). The active (anode) and the returning (cathode) electrodes will be placed bilaterally over the cerebellum (1 -2 cm below inion of occipital bone) and the right buccinator muscle, respectively Xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins will also be given

Intervention Type: OTHER

Anodal tDCS cerebral (M1) stimulation group

single session a-tDCS (2 mA, 20 min), the anode will be positioned over the lesioned M1 (C3, International 10-20 system) and the cathode would be located over the supraorbital area. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.

Intervention Type: OTHER

sham group

single session a-tDCS (2 mA, 20 min), Sham tDCS followed a similar protocol as Anodal tDCS cerebral (M1) stimulation and arrangement but stimulation for 30 s, after which the current was ramped-down and turned off for the rest of the treatment. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ability to give written consent.
• Able to walk unassisted
• Functional status allowing the participants to participate in the balance training.
• Score 6 or above on Johns Hopkins fall risk assessment tool

Exclusion Criteria

• Neurological diseases, such as Parkinson, Alzheimer
• Any history of psychological illnesses
• Receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study
• Cerebellar disorders
• use of any sedative medicines in the two days prior to the study
• any symptoms of amnesia and depression;
• Memory disorders with scores below 21 on the Mini Mental Status Examination test
• Any signs of severe motor disorders in the lower extremity which cause any movement limitation or deformity
• Any signs of radiculopathy or root lumbar spinal cord involvement
• Any visual or auditory impairment, or vertigo reports
• Use of a heart rate regulator
• Any structural deformities in the lower extremities or the spine
• Any abnormalities in the vestibular system
• History of recent fracture
• Inability to move without assistance

• Minimum Eligible Age: 40 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, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Akbar Hospital, Gujrat

Dhok Gujra, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/01141 Qurat Study1

Identifier Type: -

Identifier Source: org_study_id