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NCT Number: NCT05192759

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

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

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Key information

Conditions

Transcranial Magnetic Stimulation Freezing of Gait

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

The stimulations were performed by MagStim Rapid2.

Primary outcomes

  1. The Standing-Start 180° Turn Test (SS-180)

    Time frame: changes from baseline to 1-week post-treatment

    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.

Secondary outcomes

  1. The timed up and go test (TUG)

    Time frame: changes from baseline to 1-week post-treatment

    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.

  2. The Freezing of Gait Questionnaire (FOGQ)

    Time frame: changes from baseline to 1-week post-treatment

    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.

  3. Unified Parkinson's Disease Rating Scale III (UPDRSIII)

    Time frame: changes from baseline to 1-week post-treatment

    This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.

  4. Non-motor symptoms questionnaire

    Time frame: changes from baseline to 1-week post-treatment

    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.

  5. HAMD (Hamilton Depression Scale)

    Time frame: changes from baseline to 1-week post-treatment

    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.

  6. HAMA (Hamilton Anxiety Scale)

    Time frame: changes from baseline to 1-week post-treatment

    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.

  7. Pittsburgh sleep quality index (PSQI)

    Time frame: changes from baseline to 1-week post-treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gong-Jun JI, Ph.D.

CONTACT

[email protected]

+8655162923704

Jinmei Sun, M.S.

CONTACT

[email protected]

+8615856381782

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jan 14, 2022
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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