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

NCT05129683 | Completed DMC

• 1 other identifier: REC/01141 Qurat Study1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

Transcranial Direct Current Stimulation; Anodal Cerebral

Outcome Measures

Primary Outcomes (3)

• Changes from the base line, Berg balance scale

  Changes from the base line, Immediately after Intervention and then again after 1 hour. 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 elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. 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 were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches.

  Immediately after Intervention and then again after 1 hour.

• Timed Up and Go test

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

  Immediately after Intervention and then again after 1 hour.

• Balance Evaluation Systems Test

  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 in to 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)

  Immediately after Intervention and then again after 1 hour.

Secondary Outcomes (6)

• Montreal cognitive Scale

  1 hour

• tDCS Adverse Effects Questionnaire :

  Immediately after Intervention and then again after 1 hour.

• 6 min walk test: Distance (meters)

  Immediately after Intervention and then again after 1 hour.

• Timed 25-Foot Walk test

  Immediately after Intervention and then again after 1 hour.

• Johns Hopkins fall risk assessment Tool

  Immediately after Intervention and then again after 1 hour.

Study Arms (3)

Anodal tDCS cerebellar stimulation group:

EXPERIMENTAL

Anodal tDCS cerebellar stimulation

Other: Anodal tDCS cerebellar stimulation group

Anodal tDCS cerebral (M1) stimulation group:

EXPERIMENTAL

Anodal tDCS cerebral (M1) stimulation

Other: Anodal tDCS cerebral (M1) stimulation group

Sham Group

SHAM COMPARATOR

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

Other: sham group

Interventions

Anodal tDCS cerebellar stimulation group 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 cerebellar stimulation group:

Anodal tDCS cerebral (M1) stimulation group 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.

Anodal tDCS cerebral (M1) stimulation group:

sham group 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.

Sham Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Akbar Hospital, Gujrat

Dhok Gujra, Punjab Province, 50010, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Arshad Nawaz Malik, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: November 22, 2021
• Study Start: October 5, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)