Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by NIBS in Patients With CP

Chang Gung Medical Foundation

Status: Completed

Conditions: Cerebral Palsy

Treatments: Device: Repetitive transcranial magnetic stimulation; Device: Transcranial electric stimulation; Device: Virtual cycling training

Study type: Interventional

Funder types: Other

Identifiers

NCT04101994

201701518A0

Details and patient eligibility

About

Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and loss of dexterity are the major problems in patients with CP. A novel virtual-reality cycling training (VCT) program was to enhance promising muscle strength and motor function through promoting the participant compliance and motivation. Non-invasive brain stimulation (NIBS), such as repetitive transcranial magnetic stimulation (rTMS) and transcranial electric stimulation (TES) has potential to augment the training effects in motor neurorehabilitation via the modulation on neuroplasticity. Therefore, this study propose a novel intervention protocol to induce superior benefits on upper extremity (UE) motor function in patients with CP.

Full description

This study aims to investigate the augmented effects of VCT on neuromotor control and UE motor function by NIBS in patients with CP. We hypothesize that NIBS can augment the VCT effects on neuromotor control and UE motor function in patients with CP because combined therapy integrated peripheral modification techniques (VCT) and central modulation (NIBS). These effects may further enhance the activity of daily living (ADL), participation, and health related quality of life (HRQOL). This project is executed in the following two phases: to investigate the augmented effects of VCT on neuromotor control and UE motor function in patients with CP by rTMS in phase 1 (0-1.5 years) and tCS in phase 2 (1.5-3 years).

Enrollment: 36 patients

Sex: All

Ages: 5 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of CP according to clinical criteria
• Age 5-20 years
• No use of botulinum toxin in the past 4 months
• No significant perceptual or communication disturbances
• No other peripheral or central nervous system dysfunction
• No active inflammatory or pathologic changes in upper limb joints during the previous 6 months
• No active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
• No active problems of epilepsy and EEG without epileptiform discharge

Exclusion criteria

• Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders
• Active infectious disease, such as meningitis and encephalitis
• Patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
• Poor compliance or intolerance for the TMS therapy
• Subjects with metallic implants or pregnancy.
• EEG show epileptiform discharge
• Patients with family history of epilipsy
• Patients with symptoms that are restricted from tDCS, such as epilepsy, migraine and unstable health condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 8 patient groups

VCT and real rTMS

Experimental group

Description:

In virtual cycling training and intermittent theta burst stimulation group (VCT + iTBS group), they received VCT and iTBS (80% of active motor threshold) on affected hemisphere.

Treatment:

Device: Virtual cycling training

Device: Repetitive transcranial magnetic stimulation

VCT and sham rTMS

Experimental group

Description:

In virtual cycling training and sham theta burst stimulation group (VCT + iTBS group), they received VCT and sham TBS stimulation.

Treatment:

Device: Virtual cycling training

Device: Repetitive transcranial magnetic stimulation

real rTMS

Experimental group

Description:

In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.

Treatment:

Device: Repetitive transcranial magnetic stimulation

sham rTMS

Sham Comparator group

Description:

In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.

Treatment:

Device: Repetitive transcranial magnetic stimulation

VCT and real TES

Experimental group

Description:

In virtual cycling training and transcranial electric stimulation group (VCT + TES group), they received TES stimulation over motor cortex.

Treatment:

Device: Virtual cycling training

Device: Transcranial electric stimulation

VCT and sham TES

Experimental group

Description:

In virtual cycling training and sham transcranial electric stimulation group (VCT + sham TES group), they received VCT and sham TES stimulation.

Treatment:

Device: Virtual cycling training

Device: Transcranial electric stimulation

real TES

Experimental group

Description:

In transcranial electric stimulation group (TES group), they received TES stimulation over motor cortex.

Treatment:

Device: Transcranial electric stimulation

sham TES

Sham Comparator group

Description:

In sham transcranial electric stimulation group (sham TES group), they received sham TES stimulation.

Treatment:

Device: Transcranial electric stimulation