Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation (tDCS) vs Anodal Cerebral tDCS

NCT ID: NCT06525129

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-02-01

Brief Summary

To investigate which one of the two cerebellar and cerebral stimulation in comparison to sham stimulation is more effective in enhancing balance and postural stability in stroke patients

Conditions

Stroke

Study Design

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

Study Groups

Cerebellar stimulation group (CbSG)

Group Type: EXPERIMENTAL

Cerebellar stimulation group (CbSG)

Intervention Type: OTHER

Anodal transcranial direct current stimulation was given using a portable battery-driven brain stimulator (The Brain Stimulator v3.0 Deluxe tDCS Kit, using Professional 3x3 inches Amrex Sponge Electrodes). Skin was prepared before application of electrodes by cleaning the skin surface using alcohol swabs. In cerebellar stimulation group (CbSG) a stimulation intensity of 2mA for duration of 20 minutes. In order to avoid sudden initiation and termination of the stimulation the first and last 10 seconds of anodal tDCS application, current will gradually fade in/fade out to avoid any sudden starting or stopping of the stimulation. For the CbSG active anodal electrode was placed over the cerebellum with about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode was placed on right buccinator muscle.

Cerebral (M1) Stimulation group (MSG)

Group Type: EXPERIMENTAL

Cerebral (M1) Stimulation group (MSG)

Intervention Type: OTHER

In the M1 Stimulation Group (MSG) a similar intensity of current with 2mA was applied for a period of 20 minutes. Skin was cleaned with alcohol swab ahead of placing the electrodes. The anode was positioned over the lesioned M1 motor cortex area (C3, International 10-20 system) while the cathode was placed over the contra-lateral supraorbital area. Due to the large size of electrodes, the active electrode covered the area of M1 for the hand, arm, trunk, and the LL. Ten sessions of anodal tDCS were applied over a duration of 2 weeks. The stimulation was applied during active participation of patients in Biodex balance training.

Sham Stimulation group (SSG)

Group Type: OTHER

Sham Stimulation group (SSG)

Intervention Type: OTHER

In Sham Stimulation group (SSG) Ten sessions of anodal tDCS were applied over a duration of 2 weeks having same intensity i.e., 2 mA stimulation was used for a period of 30 seconds and then gradually ramped-down and turned off for the rest of the treatment time of 20 minutes. The same procedure for skin preparation was used as in the other two groups. Electrode placement for SSG was same as in MSG for half of the patients i.e. 8 participants; anode will be placed over the left (dominant) lesioned M1 whereas the cathode will be positioned over the right (contralateral) supraorbital area. For the other 8 participants the stimulation montages were similar to cerebellar stimulation group. The active anodal electrode was placed over the cerebellum with about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode was placed on right Buccinator Muscle.

Interventions

Cerebellar stimulation group (CbSG)

Anodal transcranial direct current stimulation was given using a portable battery-driven brain stimulator (The Brain Stimulator v3.0 Deluxe tDCS Kit, using Professional 3x3 inches Amrex Sponge Electrodes). Skin was prepared before application of electrodes by cleaning the skin surface using alcohol swabs. In cerebellar stimulation group (CbSG) a stimulation intensity of 2mA for duration of 20 minutes. In order to avoid sudden initiation and termination of the stimulation the first and last 10 seconds of anodal tDCS application, current will gradually fade in/fade out to avoid any sudden starting or stopping of the stimulation. For the CbSG active anodal electrode was placed over the cerebellum with about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode was placed on right buccinator muscle.

Intervention Type: OTHER

Cerebral (M1) Stimulation group (MSG)

In the M1 Stimulation Group (MSG) a similar intensity of current with 2mA was applied for a period of 20 minutes. Skin was cleaned with alcohol swab ahead of placing the electrodes. The anode was positioned over the lesioned M1 motor cortex area (C3, International 10-20 system) while the cathode was placed over the contra-lateral supraorbital area. Due to the large size of electrodes, the active electrode covered the area of M1 for the hand, arm, trunk, and the LL. Ten sessions of anodal tDCS were applied over a duration of 2 weeks. The stimulation was applied during active participation of patients in Biodex balance training.

Intervention Type: OTHER

Sham Stimulation group (SSG)

In Sham Stimulation group (SSG) Ten sessions of anodal tDCS were applied over a duration of 2 weeks having same intensity i.e., 2 mA stimulation was used for a period of 30 seconds and then gradually ramped-down and turned off for the rest of the treatment time of 20 minutes. The same procedure for skin preparation was used as in the other two groups. Electrode placement for SSG was same as in MSG for half of the patients i.e. 8 participants; anode will be placed over the left (dominant) lesioned M1 whereas the cathode will be positioned over the right (contralateral) supraorbital area. For the other 8 participants the stimulation montages were similar to cerebellar stimulation group. The active anodal electrode was placed over the cerebellum with about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode was placed on right Buccinator Muscle.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The study focused on individuals who had their first stroke,
• Additionally, participants needed to have a score of 6 or higher on the Johns Hopkins Fall Risk Assessment Tool (JHFRAT).
• have a functional condition that allows them to actively participate in the Biodex balancing training program.

Exclusion Criteria

• Individuals with concurrent neurological problems such as Alzheimer's, Parkinson's, or cerebellar abnormalities,
• as well as those with psychological ailments, were excluded during the initial assessment phase.
• In addition, individuals who scored below 20 on the Mini Mental Status Examination Test (MMSE),
• displayed motor disorders that affected their ability to walk or use their lower limbs,
• were currently taking sedative medications, had amnesia, depression, radiculopathy, lumbar spinal cord root involvement, auditory or visual impairments, vertigo, recent fractures, severe cardiac problems,
• or had undergone electrotherapy that affected their nervous system within the past two weeks were also not included in the study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Iqbal Tariq, PhD*

Role: STUDY_CHAIR

Riphah International University

Qurat Ul Ain, PhD*

Role: PRINCIPAL_INVESTIGATOR

Xi'an Jiaotong University

Locations

Akbar Hospital

Dhok Gujra, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Qurat ul Ain3

Identifier Type: -

Identifier Source: org_study_id