Clinical trial NCT06696547: The Effects of Cerebellar Intermittent Theta Burst Stimulation on Gait, Balance, and Disease Anxiety In Stroke Patients
Official title: The Effect of Cerebellar Intermittent Theta Burst Stimulation Combined With Conventional Rehabilitation Methods on Gait, Balance, and Disease Anxiety in Patients With Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia Following Ischemic Stroke
Keywords: Stroke
Transcranial Magnetic Stimulation
Gait
Balance
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
measure: Gait Analysis- Step Length
timeFrame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
measure: Gait Analysis- Step Width
timeFrame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
measure: Gait Analysis- Walking Speed
timeFrame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Secondary outcomes:
measure: International Falls Efficacy Scale (FES-I)
timeFrame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
measure: Barthel Index for Activities of Daily Living (BI)
timeFrame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
measure: Stroke Specific Quality of Life Scale (SS-QOL)
timeFrame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Filiz Acar Sivas, Prof, MD
role: STUDY_CHAIR
References: