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

Transcranial Magnetic Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192759
• Other study ID #: AHMU-TMS-FOG
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: Anhui Medical University
• Contact: Gong-Jun JI, Ph.D.
• Phone: +8655162923704
• Email: jigongjun[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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, and electroencephalography (EEG) record. In the second day after the last treatment, all the tests, MRI and EEG 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Freezing of Gait
• Transcranial Magnetic Stimulation

Intervention

Device:
• Transcranial Magnetic Stimulation
The stimulations were performed by MagStim Rapid2.

Locations

Country	Name	City	State
China	Cognitive Neuropsychology Lab Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Standing-Start 180° Turn Test (SS-180)	The participants walk for a distance of five meters from a sitting position and come back to the chair after turning 180° around a traffic cone in a 0.7 m × 0.7 m target box.The time and number of steps during the 180° turn (SS180) are measured.	changes from baseline to 1-week post-treatment
Secondary	The timed up and go test (TUG)	The participants walk for a distance of five meters from a sitting position and come back to the chair after turning 180° around a traffic cone in a 0.7 m × 0.7 m target box .The time and number of steps during the whole course are measured.	changes from baseline to 1-week post-treatment
Secondary	The Freezing of Gait Questionnaire (FOGQ)	This is an very common clinical motor estimating scale for evaluating FOG symptoms with 6 items and 24' in total. Higher scores indicate worse symptoms.	changes from baseline to 1-week post-treatment
Secondary	Unified Parkinson's Disease Rating Scale III (UPDRSIII)	This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.	changes from baseline to 1-week post-treatment
Secondary	Non-motor symptoms questionnaire	This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity" range from 1 to 3 and "frequency" range from 1 to 4. Higher scores indicate worse symptoms.	changes from baseline to 1-week post-treatment
Secondary	HAMD (Hamilton Depression Scale)	This scale was compiled by Hamilton in 1960, is the most common clinical to assess Depression Scale. In this study, 17 versions were selected, and there were 17 questions. The subjects were assessed for their depression in the past week. Each question scored between 0 and 4 points.Higher scores indicate more depressive symptoms.	changes from baseline to 1-week post-treatment
Secondary	HAMA (Hamilton Anxiety Scale)	This scale was compiled by Hamilton in 1959.It was one of the most commonly used scales in psychiatric clinic, including 14 items. It is often used in clinical diagnosis and degree classification of anxiety disorder. The subjects were assessed for their anxiety in the past week. Each question scored between 0 and 4 points. The higher the score, the more symptoms of anxiety.	changes from baseline to 1-week post-treatment
Secondary	Pittsburgh sleep quality index (PSQI)	This scale was developed by Dr. Buysse et al., a psychiatrist at the University of Pittsburgh in 1989. The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general.Each question scored between 0 and 3 points.The higher the score, the worse sleep quality.	changes from baseline to 1-week post-treatment