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

June 5, 2023 updated by: WANG KAI, Anhui Medical University
To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230032
        • Recruiting
        • Cognitive Neuropsychology Lab Anhui Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TBS Group
Participants will receive active transcranial magnetic stimulation (TMS) daily for 1 week
Device: Transcranial Magnetic Stimulation
The stimulations were performed by MagStim Rapid2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
changes from baseline to 1-week post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
changes from baseline to 1-week post-treatment
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.
changes from baseline to 1-week post-treatment
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.
changes from baseline to 1-week post-treatment
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.
changes from baseline to 1-week post-treatment
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.
changes from baseline to 1-week post-treatment
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.
changes from baseline to 1-week post-treatment
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.
changes from baseline to 1-week post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AHMU-TMS-FOG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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