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

Ankara City Hospital

Status: Completed

Conditions: Hemiplegia Following Ischemic Stroke

Treatments: Device: Transcranial Magnetic Stimulation; Device: Transcranial Magnetic Stimulation Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT06696547

AnkaraCHBilkent-PMR-MK-01

Details and patient eligibility

About

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.

Full description

Loss of balance and gait functions, which are neurological impairments related to stroke, are among the common functional losses depending on the affected brain region. Reduced independence in daily living activities can lead to increased anxiety during ambulation, risk of falling and fear of falling. Studies have shown that applying theta burst stimulation (TBS) to the cerebellum has long-term effects on the excitability of the cerebello-thalamo-cortical pathways and stimulates synaptic plasticity through various mechanisms. In the literature, there are studies examining the effects of cerebellar iTBS on balance and walking functions in stroke patients, but the number of studies are quite limited.

This study was planned as a prospective, randomized, sham-controlled clinical study. According to the statistical analysis 30 patients who were registered at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital between February 2022 and April 2023 and met the study criteria were included. The patients were divided into two groups: active (n=15) and sham (n=15). Each group received 30 sessions of either active or sham cerebellar iTBS (CRB-iTBS). Additionally, patients received therapeutic interventions from a physiotherapist, including range of motion exercises, stretching, neurophysiological exercises, balance-coordination training, active-assistive mobilization, and exercises for daily living.

The CRB-iTBS treatment targeted the cerebellum on the opposite side to the cerebral lesions, administered in a total of 30 sessions, twice a day with a 5-minute interval between sessions, over a period of 3 weeks. Each stimulation session consisted of 3-burst pulses at a frequency of 50 Hz, with a 10-second repetitive cycle of 2-second stimulations lasting a total of 190 seconds, delivering 600 pulses per session. Each day, a total of 1200 pulses were administered over two sessions, spaced 5 minutes apart. Patients in the sham CRB-iTBS group received the same protocol with a sham coil that visually resembled the active coil.

Clinical evaluations were conducted three times for each patient: Baseline (before treatment), 3rd week (at the and of treatment), and 6th week.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Active CRB-iTBS

Active Comparator group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation

Sham CRB-iTBS

Sham Comparator group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation Sham