Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05192759
Other study ID # AHMU-TMS-FOG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04927364 - Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder N/A
Recruiting NCT06193278 - Individual Neuromodulation for PDS N/A
Recruiting NCT05973019 - rTMS Improves Functions in Spinocerebellar Ataxia N/A
Completed NCT05074524 - Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings N/A
Recruiting NCT05889117 - Brain Stimulation for Concussion N/A
Recruiting NCT03974659 - Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients N/A
Recruiting NCT05613686 - Theta Burst Stimulation for Motor Recovery N/A
Completed NCT04014491 - The Effects of Exercise Training on Corticospinal System in Overhead Athletes With Shoulder Impingement Syndrome N/A
Recruiting NCT05914038 - Individualized rTMS for Motor Recovery in Stroke Patients N/A
Recruiting NCT06084455 - TMS-evoked Potentials During Aerobic Exercise N/A
Completed NCT05566444 - TMS-evoked Potentials During Heat Pain N/A
Enrolling by invitation NCT04313530 - TMS Treatment in Multiple System Atrophy With Fatigue N/A
Completed NCT04209309 - Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal N/A
Terminated NCT04486222 - Accelerated Bilateral rTMS on Geriatric Depression N/A
Recruiting NCT05467657 - Transcranial Magnetic Stimulation on Somtosensory Cortex Enhances Motor Learning in People With Stroke N/A
Recruiting NCT05896332 - rTMS in Older Adults With MCI and AUD Phase 1
Recruiting NCT04727177 - Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia Early Phase 1
Recruiting NCT04906603 - Theta Burst Stimulation for Headaches After Traumatic Brain Injury N/A
Recruiting NCT03590327 - Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment N/A
Recruiting NCT05843240 - Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke N/A