Clinical trial NCT04282538: Efficacy of rTMS and tDCS as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Cerebrovascular Disease
Gait Dysfunction, Neurologic
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a prospective, randomized, single-blind, parallel-controlled, multicenter clinical study to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation and transcranial direct current stimulation assisted rehabilitation in the treatment of cerebrovascular disease-related gait disorders.

Detailed description: This study was a prospective, randomized, single-blind, parallel-controlled, multicenter clinical study. The main purpose was to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation and transcranial direct current stimulation assisted rehabilitation in the treatment of cerebrovascular disease-related gait disorders. The secondary objective was to assess the effects of these two types of neuromodulation on cognitive, emotional, and daily living abilities.

Eligibility criteria: Inclusion Criteria:

1. Group A: Gait Dysfunction of Hemiplegia

   * Age ≥ 35 years old, ≤ 75 years old;
   * There was a cerebral infarction event in the past ≥ 2 months, leaving unilateral lower extremity paralysis, muscle strength IV to V- grade;
   * Brunnstrom staging: lower limb of paralysis (IV-V grade), lower limb of healthy side (IV-V grade), upper limbs (IV-V grade), hands (IV-V grade);
   * Able to stand for 5 minutes without assistance, without gait aid, and to walk independently for 5 minutes without stopping;
   * Mini-mental state examination (MMSE) \> 17 points, able to complete cognitive and gait assessments.
2. Group B: Frontal Gait Dysfunction

   * Age ≥ 35 years old, ≤ 75 years old;
   * Meet the frontal gait characteristics: a) Balance dysfunction: wide step base, trunk swing, increased fall, decreased trunk movement control, and autonomous activity dysfunction; b) difficulty in starting, dragging and freezing; c) without limb ataxia, dysarthria, nystagmus, decreased facial expression, decreased upper limb joint activity, upper motor neuron impaired signs, and resting tremor;
   * There was a cerebral infarction event ≥ 2 months, or asymptomatic stroke event but the head MRI suggested single or multiple lacunar infarction or ischemic lesion (diameter ≤ 2cm);
   * limb muscle strength V- to V grade, and the muscle strength of both limbs is the same;
   * Able to stand for 5 minutes without assistance, without gait aid, to walk independently for 5 minutes;
   * Able to complete cognitive and gait assessments.

Exclusion Criteria:

* Other gait abnormalities caused by other diseases, such as Parkinson's disease, hydrocephalus, cerebellar disease, vestibular system disease, extrapyramidal abnormalities, abnormalities of proprioceptive sensibility, visual abnormalities, auditory abnormalities, peripheral nerves and musculoskeletal diseases;
* Symptomatic cerebral infarction \<2 months; Severe nervous system diseases, such as previous cerebral hemorrhage, history of subarachnoid hemorrhage, craniocerebral trauma, cerebral vascular malformation, brain tumor, central nervous system infection, demyelinating disease, epilepsy, myelopathy, etc.;
* Severe cognitive impairment, major depression, and aphasia disable to finish the cognitive and gait assessments;
* serious cardiovascular, pulmonary, blood, rheumatism and other complications, pregnancy;
* Metal implants such as pacemakers or cochlear implants;
* Taking drugs that affect cortical excitability: such as antiepileptic drugs, sedation, benzodiazepines, antidepressants, dopamine, amphetamines, etc.;
* long-term heavy drinking: the alcohol content of men drinking more than 168g per week, women more than 112g;
* Neurological rehabilitation treatment was received within 1 month before the start of the trial.

Primary outcomes:
measure: Velocity of 10m walking test
timeFrame: 12 weeks
Secondary outcomes:
measure: 10m walking test
timeFrame: 12 weeks
measure: Turn time of time up and go test
timeFrame: 12 weeks
measure: Dual-task walking
timeFrame: 12 weeks
measure: Tinetti Balance and Gait Analysis
timeFrame: 12 weeks
measure: Mini-mental state examination (MMSE)
timeFrame: 12 weeks
measure: Montreal cognitive assessment (MoCA)
timeFrame: 12 weeks
measure: Symbol digit modalities test (SDMT)
timeFrame: 12 weeks
measure: Color word test (CWT)
timeFrame: 12 weeks
measure: Hamilton depression scale (HAMD)
timeFrame: 12 weeks
measure: Instrumental activities of daily living (IADL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Eighth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Huadong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Xuhui District Central Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Xin Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: