NCT06696547

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

The Effect of Cerebellar Intermittent Theta Burst Stimulation Combined With Conventional Rehabilitation Methods on Gait, Balance, and Disease Anxiety in Patients With Ischemic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hemiplegia Following Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Coil
DEVICE	Transcranial Magnetic Stimulation Sham	Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Sham Coil

Timeline

• Start date: 2022-02-28
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2024-11-20
• Last updated: 2024-11-20

Locations

1 site across 1 country: Turkey (Türkiye)