Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait

Anhui Medical University

Status: Enrolling

Conditions: Freezing of Gait; Transcranial Magnetic Stimulation

Treatments: Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05192759

AHMU-TMS-FOG

Details and patient eligibility

About

To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.

Full description

This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of TBS among patients with FOG. Forty patients with FOG were treated with TBS for 1 week.

Before the TBS treatment, the Freezing of Gait Questionnaire, the Timed up and go test, the Standing Start 180° Turning Test, the Unified Parkinson's Disease Rating Scale, and the Non-motor Symptom Scale, the Pittsburgh sleep quality index were obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(mini-mental state examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton depression/anxiety scale) and magnetic resonance imaging (MRI) scan in multimodalities, electroencephalography (EEG) record and fNIRS.

In the second day after the last treatment, all the tests, MRI 、EEG and fNIRS were reassessed. Patients were instructed to focus their answers on the past 1 week.

The clinical symptom and cognition of participants were followed in one month and two month after the last treatment.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosis of FOG with expertise in movement disorders.
2. the score of item 3 of the FOG questionnaire ≥1.
3. ongoing treatment with a stable dose of any medication for 2 months.
4. 40 years of age or older.

Exclusion criteria

1. a history of addiction, psychiatric disorders, or neurological diseases other than PD.
2. focal brain lesions on T1-/T2-weighted fluid-attenuated inversion recovery images.
3. anti-PD medication adjustments during rTMS treatment.
4. history of substance abuse within the past 6 months.
5. nonremovable metal objects in or around the head.
6. previously received rTMS treatment.
7. prior history of seizure or history in first-degree relatives.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

TBS Group

Experimental group

Description:

Participants will receive active transcranial magnetic stimulation (TMS) daily for 1 week

Treatment:

Device: Transcranial Magnetic Stimulation