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Completed

NCT Number: NCT06525129

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akbar Hospital

Dhok Gujra, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • The inclusion criteria mandated that participants must have the ability to give written consent, walk without any help, and
  • 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.

Treatment and study plan

Cerebellar stimulation group (CbSG)

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)

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)

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.

Primary outcomes

  1. Biodex balance system

    Time frame: 2 weeks

    The biodex balance system based specific dynamic postural tests were delineated for implementation on both static and dynamic levels. Postural stability tests were performed at three levels of stability: 12 (maximum stability = static), 7 (moderate stability) and 3 (slight stability).

  2. Berg balance scale

    Time frame: 2 weeks

    The Berg balance scale (BBS) is used to assess the participant's ability to retain stability.

    The BBS is a widely used test for the assessment of the elderly population with impairment of balance and individuals with neurological disorders while sitting, standing, and transferring. This test included both static and dynamic type tasks. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points. The scale has been shown to be reliable and valid in stroke patients. A cut-off score of 45 points is used for fall prediction. The BBS involves 14 tasks: a total score of 56. Equipment required for this test was a stopwatch or watch with a second hand and a ruler or other indicator of 2, 5, and 10 inches.

  3. Timed up and go test

    Time frame: 2 weeks

    The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall. The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down. The time taken to complete this task will be measured. The test will be informed three times. The time required to complete this task will be measured from a stopwatch. The average values from 3 trials, with 1-min rest between each trial, were used for data analysis.

  4. Bestest balance evaluation system

    Time frame: 2 weeks

    Changes from the base line, immediately after Intervention and then again after 1 hour.

    Balance Evaluation Systems Test (BESTest) is a 36-item assessment of balance impairments across 6 postural control contexts. Total score of 108 points total, calculated into a percentage score (0-100%). Also, total sub-scores exist for each above listed system. Item- level scores range from 0 (severe impairment) to 3 (no impairment)

  5. TDCSs adverse effects questionnaire

    Time frame: 2 weeks

    Transcranial Direct-Current Stimulation (tDCS) adverse effects questionnaire:

    Do you experience any of the following symptoms or side- effects? Headache, Neck pain, Scalp pain, Tingling, Itching, burning sensation, Skin redness, Sleepiness, Trouble concentrating, Acute mood change, Others (specify) for each symptom patient can give value (1-4) (1, absent; 2, mild; 3, moderate; 4, severe). If present: Is this related to tDCS?

    (1, none; 2, remote; 3, possible; 4, probable; 5, definite)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparison of Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Its Components and Postural Stability in Stroke Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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