- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04707378
Navigated Repetitive Transcranial Magnetic Stimulation for Parkinson's Disease With Depression or Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lijuan Wang, Ph.D
- Phone Number: +86 020 83827812-10402
- Email: wljgd68@163.com
Study Contact Backup
- Name: Shuolin Jiang, BS
- Phone Number: +86 020 83827812-50653
- Email: jiangshuolin@gmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- Guangdong Provincial People's Hospital
-
Contact:
- Shuolin Jiang, BS
- Phone Number: +86 020 83827812-50653
- Email: jiangshuolin@gmail.com
-
Contact:
- Lijuan Wang, Ph.D, MD
- Phone Number: +86 020 83827812-10402
- Email: wljgd68@163.com
-
Principal Investigator:
- Lijuan Wang, Ph.D.
-
Sub-Investigator:
- Limin Wang, MS
-
Sub-Investigator:
- Yihui Qiu, MS
-
Sub-Investigator:
- Kun Nie, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Patients between 18 and 85 years of age with idiopathic PD (diagnosed as "confirmed PD" or "likely PD" according to the 2015 MDS Parkinson's diagnostic criteria), regardless of gender.
2. Meet the DSM-IV diagnostic criteria for depressive episodes. 3. If there is a combination of anti-Parkinsonian medications, the anti-Parkinsonian medication regimen and dose must remain stable for ≥ 28 days and be maintained at that dose for the duration of treatment.
4. Not taking any antidepressant medication for the last 2 months. 5. the subject/their legal representative is able to comply with the study protocol and visit schedule.
6. The patient or his/her legal guardian agrees to participate in this trial and signs an informed consent form.
Exclusion Criteria:
1. Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superimposed syndrome.
2. PD patients with persistent head tremor. 3. Dementia. 4. Patients with suicidal tendencies and psychotic symptoms. 5. Patients with consciousness disorders, history of stroke, severe neurological/psychiatric disorders such as transient ischemic attack and other severe organic diseases within 1 year prior to screening (Visit 1) 6. Have contraindications to rTMS(e.g., implantation of cochlear implants, deep brain stimulation, pacemakers, medical pumps, and other metal-containing devices near stimulation coils; history of epilepsy; history of traumatic brain injury, brain tumor, encephalitis, cerebrovascular disease, cerebral metabolic disease; sleep deprivation, unrecovered jet lag, intoxication, overexertion; pregnancy; severe or recent heart disease, etc.) 7. Have contraindications to MRI scanning (including metal implants, retractors, braces, or claustrophobia).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: active left DLPFC navigated-rTMS
Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions).
In each rTMS session, 1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC.
Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC.
|
Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions).
In each rTMS session, 1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC.
Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC.
For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
|
SHAM_COMPARATOR: sham left DLPFC navigated-rTMS
Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions).
In each rTMS session, 1200 pulses of sham stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC.
Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (sham) over the left DLPFC.
|
Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions).
In each rTMS session, 1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC.
Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC.
For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Depression Scale(HAMD)
Time Frame: 1 months
|
The Hamilton Depression Rating Scale (HAMD) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression.
Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74.
A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.
|
1 months
|
Beck Depression Inventory(BDI)
Time Frame: 1 months
|
The Beck Depression Inventory (BDI) is a 21-item self-report questionaire that measures depressive symptoms.
Each item is scored on a scale of 0-3, and items are summated to yield a total score.
A higher score is indicative of greater symptoms of depression.
Total scores may range between 0 and 63.
A score greater than or equal of 14 is suggestive of clinically significant symptoms.
|
1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Anxiety Scale(HAMA)
Time Frame: 1 months
|
The Hamilton Anxiety Rating Scale (HAMA) is a designed to assess symptoms of anxiety.
Items are scored with a range of 0-4.
A total score is then calculated of all items which can range from 0 to 54.
A higher score is indicative of more anxiety symptoms, and a lower score post-tx is indicative of better outcome.
|
1 months
|
Beck Anxiety Inventory(BAI)
Time Frame: 1 months
|
The Beck Anxiety Inventory (BAI) is a 21-item self-report questionaire that measures Anxiety symptoms.
Each item is scored on a scale of 0-3, and items are summated to yield a total score.
A higher score is indicative of greater symptoms of anxiety.
Total scores may range between 0 and 63.
A score greater than or equal of 8 is suggestive of clinically significant symptoms.
|
1 months
|
Mini-mental State Examination(MMSE)
Time Frame: 1 months
|
The MMSE consists of 2 parts: language (time orientation (5 items), registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function.
A positive change score indicates improvement from baseline.
|
1 months
|
Montreal Cognitive Assessment Scale(MoCA)
Time Frame: 1 months
|
The MoCA explores 8 cognitive domains: visuospatial/executive (score range form 0 to 5), naming(0-3), attention (0-5), language (0-3), abstraction(0-2), delayed recall(0-5), and orientation(0-6).
The MoCA score was not corrected according to education level as advised by Gagnon and colleagues (2013).
Its normal value was≥26 as proposed.
A lower score indicates more severe cognitive impairment.
|
1 months
|
Named test of the Aphasia Battery of Chinese
Time Frame: 1 months
|
The Aphasia Battery of Chinese(ABC) was compiled by Surong Gao et al in 1988 in accordance with the basic principles of aphasia inspection.It is mainly based on the Western Aphasia Battery (WAB), which has been developed through exploration and modification in combination with Chese national conditions and clinical experience.The named test is one of the subtest of the ABC.A total score is then calculated of all items which can range from 0 to 82.
A higher score is indicative of worse outcome.
|
1 months
|
Similarity test
Time Frame: 1 months
|
The similarity test includes 13 items scored with a range of 0-2.
In each item, participants are given two words or concepts and have to describe how they are similar.
A lower score indicates more severe abstract verbal reasoning and semantic knowledge impairment.
|
1 months
|
Symbol Digit modalities test(SDMT)
Time Frame: 1 months
|
The Symbol Digit modalities test(SDMT) consists of nine digit-symbol pairs followed by a list of digits.
Under each digit the subject should write down the corresponding symbol as fast as possible.
The number of correct symbols within the 90 sec is measured.
|
1 months
|
Verbal fluency test(VFT)
Time Frame: 1 months
|
The verbal fluency test is a kind of psychological test in which participants have to produce as many words as possible from a category in a given time (usually 60 seconds).
A 60-second limit for responses within each category was allowed.
Higher scores represent better performance.
|
1 months
|
Logical memory test(LMT)
Time Frame: 1 months
|
The Logical Memory, subtest of the WMS-R is a standardized assessment of narrative episodic memory.
A short story is orally presented, and the examinee is asked to recall the story immediately.
|
1 months
|
Delayed memory test(DMT)
Time Frame: 1 months
|
Approximately 5 and 30 min later of the Logical memory test, recall of the story is again elicited, which is called delayed memory test.
|
1 months
|
Digit span test(DST)
Time Frame: 1 months
|
In digit span test, participants must recall a series of numbers in order.
A lower score indicates more severe working memory, attention, encoding and auditory processing impairment.
|
1 months
|
Ten point clock test
Time Frame: 1 months
|
The ten point clock test is a reliable test of cognitive function.
A total score is then calculated of all items which can range from 0 to 10.
A higher score is indicative of better outcome.
|
1 months
|
Uniform Parkinson's Disease Rating Scale Ⅲ(UPDRSⅢ)
Time Frame: 1 months
|
The motor section of the Unified Parkinson Disease Rating Scale (UPDRSⅢ) is covers the motor evaluation of disability and includes ratings for tremor, slowness (bradykinesia), stiffness (rigidity), and balance; part IV covers a number of treatment complications including ratings of involuntary movements (dyskinesias), painful cramps (dystonia), and irregular medication responses (motor fluctuations).
It consists of 27 items, each are scored with a range of 0-4, with total score ranges from 0 to108.
A higher score is indicative of more severe motor symptoms.
|
1 months
|
Modified Hoehn & Yahr scale(H-Y)
Time Frame: 1 months
|
The Hoehn&Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.
It was originally published in 1967 in the journal Neurology by Melvin Yahr and Margaret Hoehn and included stages 1 through 5. Since then, a modified Hoehn&Yahr scale was proposed with the addition of stages 1.5 and 2.5 to help describe the intermediate course of the disease.
A higher score is indicative of more severe movement impairment.
|
1 months
|
Activity of Daily Living Scale(ADL)
Time Frame: 1 months
|
ADL was developed by Lawton and Brody in 1969.It consists of Physical self-maintenance Scale (PSMS) and Instrumental Activities of Daily Living Scale (IADL).It is mainly used to assess the daily life ability of the subjects.
The total score below 14 points is indicative normal.More than 16 points is indicative functional decline.The highest score is 56.
|
1 months
|
Parkinson's Disease Questionnaire(PDQ-39)
Time Frame: 1 months
|
The Parkinson's Disease Questionnaire is designed to address aspects of functioning and well-being for those affected by Parkinson's disease.
Substantial evidence is available to suggest that the PDQ is reliable, valid, responsive, acceptable and feasible as the tool for the assessment of quality of life in Parkinson's disease patients.
There are 39 questions in the long form Parkinson's Disease Questionnaire, with 8 discrete scales:mobility (10 items),activities of daily living (6 items),emotional well-being (6 items),stigma (4 items),social support (3 items),cognitions (4 items),communication (3 items),bodily discomfort (3 items) .
Items are scored with a range of 0-4.
A total score is then calculated of all items which can range from 0 to 156.
A higher score is indicative of worse outcome.
|
1 months
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 1 months
|
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults.
It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.
A total score is then calculated of all items which can range from 0 to 21.
A higher score is indicative of worse outcome.
|
1 months
|
Epworth Sleepiness Scale (ESS)
Time Frame: 1 months
|
The Epworth sleepiness scale (ESS) is a self-administered questionnaire that's routinely used to assess daytime sleepiness.
The person filling in the questionnaire rates how likely they are to doze off during the day in different situations.
Each of the activities listed has an assigned score from 0 to 3 that indicates how likely a person is to fall asleep during the activity, and the total score can range from 0 to 24.
A higher score is associated with increased sleepiness.
|
1 months
|
Parkinson's Disease Sleep Scale (PDSS-2)
Time Frame: 1 months
|
The Parkinson's Disease Sleep Scale (PDSS-2) allows people with Parkinson's Disease to self-rate and quantify the level of sleep disruption being experienced.
Each of the sleep disruption listed has an assigned score from 0 to 4 that indicates the sleep disruption frequency within a week, and the total score can range from 0 to 60.
A higher score is associated with increased sleep disruption.
|
1 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lijuan Wang, Ph.D, Guangdong Provincial People's Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Cognition Disorders
- Depression
- Depressive Disorder
- Parkinson Disease
- Cognitive Dysfunction
Other Study ID Numbers
- GDREC2020181H(R1)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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