The Effects of Cerebellar Intermittent Theta Burst Stimulation on Gait, Balance, and Disease Anxiety In Stroke Patients

NCT06696547 | Completed

• 1 other identifier: AnkaraCHBilkent-PMR-MK-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Our study was designed to investigate the effect of cerebellar intermittent theta burst stimulation (iTBS) combined with conventional rehabilitation methods on balance, gait and disease anxiety in patients with ischemic stroke who have residual balance and gait disturbance, using clinical measurement parameters.

Conditions

Hemiplegia Following Ischemic Stroke

Keywords

Stroke; Transcranial Magnetic Stimulation; Gait; Balance

Outcome Measures

Primary Outcomes (4)

• Berg Balance Scale (BBS)

  This is a scale used to evaluate patients' balance during 14 different activities. These activities include: sitting to standig, standing unsupported, sitting unsupported, standing to sitting, transfers, standing unsupported with eyes closed, standing with feet together, reaching forward while standing, picking up an object from the floor, looking back over the shoulder on both the right and left sides, turning 360 degrees, placing a foot on a stool, standing in a toe-heel position, and standing on one foot. The total score after performing the test determines the predicted risk of falls. The minimum score on the test is 0, and the maximum score is 56. Scores are classified as follows: 0-20 indicates a high risk of falling, 21-40 indicates a moderate risk of falling, and 41-56 indicates a low risk of falling.

  Baseline (before treatment), 3rd week (at the end of treatment), 6th week

• Gait Analysis- Step Length

  The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included step length (cm).

  Baseline (before treatment), 3rd week (at the end of treatment), 6th week

• Gait Analysis- Step Width

  The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included step width (cm).

  Baseline (before treatment), 3rd week (at the end of treatment), 6th week

• Gait Analysis- Walking Speed

  The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included walking speed (km/h).

  Baseline (before treatment), 3rd week (at the end of treatment), 6th week

Secondary Outcomes (4)

• International Falls Efficacy Scale (FES-I)

  Baseline (before treatment), 3rd week (at the end of treatment), 6th week

• Barthel Index for Activities of Daily Living (BI)

  Baseline (before treatment), 3rd week (at the end of treatment), 6th week

• Stroke Specific Quality of Life Scale (SS-QOL)

  Baseline (before treatment), 3rd week (at the end of treatment), 6th week

• Hospital Anxiety and Depression Scale (HADS)

  Baseline (before treatment), 3rd week (at the end of treatment), 6th week

Study Arms (2)

Active CRB-iTBS

ACTIVE COMPARATOR

Patients received a total of 30 sessions active CRB-iTBS targeting contralesional lateral cerebellum, 5 days a week for 3 weeks. The cerebellar region to be targeted, on the opposite side of the cerebral lesion, was determined by measuring 3 cm lateral and 1 cm inferior of the inion, which is the anatomical prominence on the occipital bone (3L1I). Stimulation intensity was set at 80% of the active motor threshold (AMT). AMT was defined as the lowest intensity required for a motor-evoked potentials (MEP) above 200 µV in at least 50% of 10 trials when the patient was contracting targeted muscle 10% on the maximum voluntary contraction. Stimulation was administered as 3-burst pulses at a frequency of 50 Hz, with 2-second stimulation repeated every 10 seconds period. This continued for a total duration of 190 seconds, delivering 600 pulses. Each CRB-iTBS session was performed in 2 sessions before daily rehabilitation programs. Thus, 1200 pulses were applied per day.

Device: Transcranial Magnetic Stimulation

Sham CRB-iTBS

SHAM COMPARATOR

Patients received a total of 30 sessions sham CRB-iTBS targeting contralesional lateral cerebellum, 5 days a week for 3 weeks. The cerebellar region to be targeted, on the opposite side of the cerebral lesion, was determined by measuring 3 cm lateral and 1 cm inferior of the inion, which is the anatomical prominence on the occipital bone (3L1I). However, sham coil was used for stimulation. Therefore, no real stimulation was applied to the patients. Instead, a sensation mimicking real stimulation was created through the sham coil, with sounds and sensations on the scalp as if stimulation were occurring. Each sham CRB-iTBS session was performed in 2 sessions before daily rehabilitation programs.

Device: Transcranial Magnetic Stimulation Sham

Interventions

Transcranial Magnetic Stimulation DEVICE

Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Coil

Active CRB-iTBS

Transcranial Magnetic Stimulation Sham DEVICE

Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Sham Coil

Sham CRB-iTBS

Eligibility Criteria

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

You may qualify if:

• First ischemic stroke,
• Duration between 2 months to 2 years post-stroke,
• Hemiparesis and residual gait and balance disorders related to the lesion in the MCA area (Berg Balance Scale score \< 40),
• Lower extremity Brunnstrom value of at least 3 ,
• Mini Mental State Examination ≥ 24,
• Between 18-80 years old

You may not qualify if:

• History of seizures,
• Severe general impairmet or concomittant disease,
• Using benzodiazepines, baclofen or antidepressants,
• Having a cardiac pacemaker, cochlear implant, metallic implants in the brain or skull,
• Pregnancy,
• Under 18 or over 80 years old

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Filiz Acar Sivas, Prof, MD

  Ankara City Hospital Bilkent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal Investigator

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 20, 2024
• Study Start: February 28, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)