AzTrials
AzTrials

Parkinson DiseaseNCT04707378

Navigated Repetitive Transcranial Magnetic Stimulation for Parkinson's Disease With Depression or Cognitive Impairment

A study testing repetitive transcranial magnetic stimulation(rTMS) in people with Parkinson Disease and Depression, run by Guangdong Provincial People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Depressive symptoms are common non-motor symptoms in patients with Parkinson's disease and seriously affect the quality of life and prognosis of patients. Currently, treatment measures for patients with Parkinson's disease with depression are mainly limited to pharmacotherapy, but the side effects of antidepressants… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
repetitive transcranial magnetic stimulation(rTMS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteChina
Study dates
30 Dec 2020to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Lijuan Wang, Ph.D, MD, +86 020 83827812-10402, wljgd68@163.com

    Shuolin Jiang, BS, +86 020 83827812-50653, jiangshuolin@gmail.com

    Recruiting

Other trials in China

About this study

Depressive symptoms are common non-motor symptoms in patients with Parkinson's disease and seriously affect the quality of life and prognosis of patients. Currently, treatment measures for patients with Parkinson's disease with depression are mainly limited to pharmacotherapy, but the side effects of antidepressants and their interaction with anti-Parkinsonian drugs limit the use of pharmacotherapy. Repetitive transcranial magnetic stimulation (rTMS) is a new painless and non-invasive neuromodulation technique that is commonly used in the treatment of depression. As the number of people with Parkinson's disease increases in China, the number of patients with Parkinson's disease and depression requiring rTMS treatment will also increase. The size and shape of individual brains, the distance between the stimulation coil and the responding neuronal tissue, and the location and orientation of anatomical structures are all different, and the use of common localization methods is usually limited by these individual anatomical differences. The traditional method relies on manual positioning of the coil, which is time-consuming and inefficient, and it is difficult to meet the requirements of position, angle, and coil orientation simultaneously. Studies have shown that the benefits of using navigation for rTMS treatment are up to twice as high as those of non-navigation methods. Therefore precise localization is a must for the future standardized application of rTMS in the development of patients with Parkinson's disease with depression. In this study, we applied repetitive transcranial magnetic stimulation with neuronavigation to treat patients with Parkinson's disease and depression, and reconstructed cephalometric models with individual cranial imaging data to individualize and precisely target stimulation sites, making rTMS more precise and effective in treating patients with Parkinson's disease and depression, and providing new avenues for further clinical and scientific research.

Being tested
repetitive transcranial magnetic stimulation(rTMS)
Keywords
Parkinson's Disease, rTMS, Depression, Cognitive Impairment, Navigation, Dorsal Prefrontal Cortex
Medical subject headings
Parkinson Disease, Depression, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • repetitive transcranial magnetic stimulation(rTMS)Device

    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.

Study groups in NCT04707378
Study groupRoleWhat they receive
active left DLPFC navigated-rTMSActive comparatorEach 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.
Receives: Device: repetitive transcranial magnetic stimulation(rTMS)
sham left DLPFC navigated-rTMSSham comparatorEach 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.
Receives: Device: repetitive transcranial magnetic stimulation(rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Scale(HAMD)

    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.

    Measured: 1 months

  2. Beck Depression Inventory(BDI)

    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.

    Measured: 1 months

Secondary outcomes (19)
  1. Hamilton Anxiety Scale(HAMA)

    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.

    Measured: 1 months

  2. Beck Anxiety Inventory(BAI)

    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.

    Measured: 1 months

  3. Mini-mental State Examination(MMSE)

    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.

    Measured: 1 months

  4. Montreal Cognitive Assessment Scale(MoCA)

    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.

    Measured: 1 months

  5. Named test of the Aphasia Battery of Chinese

    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.

    Measured: 1 months

  6. Similarity test

    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.

    Measured: 1 months

  7. Symbol Digit modalities test(SDMT)

    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.

    Measured: 1 months

  8. Verbal fluency test(VFT)

    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.

    Measured: 1 months

  9. Logical memory test(LMT)

    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.

    Measured: 1 months

  10. Delayed memory test(DMT)

    Approximately 5 and 30 min later of the Logical memory test, recall of the story is again elicited, which is called delayed memory test.

    Measured: 1 months

  11. Digit span test(DST)

    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.

    Measured: 1 months

  12. Ten point clock test

    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.

    Measured: 1 months

  13. Uniform Parkinson's Disease Rating Scale Ⅲ(UPDRSⅢ)

    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.

    Measured: 1 months

  14. Modified Hoehn & Yahr scale(H-Y)

    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.

    Measured: 1 months

  15. Activity of Daily Living Scale(ADL)

    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.

    Measured: 1 months

  16. Parkinson's Disease Questionnaire(PDQ-39)

    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.

    Measured: 1 months

  17. Pittsburgh Sleep Quality Index (PSQI)

    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.

    Measured: 1 months

  18. Epworth Sleepiness Scale (ESS)

    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.

    Measured: 1 months

  19. Parkinson's Disease Sleep Scale (PDSS-2)

    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.

    Measured: 1 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start30 Dec 2020
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04707378
Sponsor's protocol ID
GDREC2020181H(R1)
Status last verified
Sep 2020
First submitted
11 Jan 2021
Last updated
13 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing repetitive transcranial magnetic stimulation(rTMS) in people with Parkinson Disease and Depression, run by Guangdong Provincial People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lijuan Wang, Ph.D (+86 020 83827812-10402, wljgd68@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Scale(HAMD) (time frame: 1 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in