Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease

Fondazione Europea di Ricerca Biomedica Ferb Onlus

Status: Unknown

Conditions: Gait Disorders, Neurologic; Parkinson Disease; Parkinson; Gait, Festinating; Parkinsonism

Treatments: Device: repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04238000

19/03

Details and patient eligibility

About

Objective of the study:

To test the efficacy of theta burst cerebellar stimulation on dual task walking in Parkinson's disease using a cross-over design and wearing sensors technology

Design:

Twenty Parkinson's disease patients with no dementia will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.

Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology .

Full description

There are no medical effective treatments for dual-task gait in Parkinson's disease. Imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for dual-task walking for theta Burst repetitive Transcranial magnetic stimulation

Objective of the study:

To test the efficacy of theta burst cerebellar stimulation on gait in Parkinson's disease using a cross-over design and wearing sensors technology

Design:

Parkinson's disease patients able to walk and without dementia/behavioral disturbances will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.

Repetitive cerebellar theta burst stimulation will be performed by Duo-Mag XT100, using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject.

A sample size of 20 subjects with complete stimulation (2 stimulations per subject, for a total number of stimulation)

Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology.

Sensors assessment:

The following gait parameters will be evaluated in normal and cognitive/motor dual-tasks:

i) step length ii) step variability iii) step phases iv) turning speed

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• established Parkinson's disease
• ability to stand alone and walk without support

Exclusion criteria

• dementia or behavioral alterations
• contraindication to stimulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Real Stimulation

Active Comparator group

Description:

Cerebellar Repetitive theta burst stimulation will be performed using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject.

Treatment:

Device: repetitive transcranial magnetic stimulation

Sham Stimulation

Placebo Comparator group

Description:

The rTMS coil stimulation will be applied in the same position of the real stimulation. The Stimulation will be performed like in the real arm with the difference that the coil will be masked and thus will be inactive. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation)

Treatment:

Device: repetitive transcranial magnetic stimulation