Standardization and Optimization of TMS Protocols for the Treatment of PD With Depression or Cognitive Impairment
1 other identifier
interventional
252
1 country
10
Brief Summary
The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in Parkinson's disease patients with depression or cognitive impairment. The study consists of seven total visits to all. Compensation will be provided for each visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedStudy Start
First participant enrolled
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 13, 2021
July 1, 2020
3.4 years
May 29, 2018
January 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
3 months
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.
3 months
Secondary Outcomes (19)
Mini-mental State Examination（MMSE）
3 months
Montreal Cognitive Assessment Scale（MoCA）
3 months
Named test of the Aphasia Battery of Chinese
3 months
Similarity test
3 months
Symbol Digit modalities test（SDMT）
3 months
- +14 more secondary outcomes
Study Arms (4)
left and right DLPFC active treatment
ACTIVE COMPARATORIntervention: repetitive transcranial stimulation (rTMS) Each patient will be given 5 treatment sessions per week for 2 weeks (a total of 10 sessions).In each rTMS conditioning session,1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left and rigt DLPFC.Each session is 45 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC and 1Hz over the right DLPFC，Interval of 5 minutes each side.During rTMS blocks, the coil will be oriented tangential to the surface.
left DLPFC active and right DLPFC sham treatment group
ACTIVE COMPARATOREach patient will be given 5 treatment sessions per week for 2 weeks (a total of 10 sessions).In each rTMS conditioning session,1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left and rigt DLPFC.Each session is 45 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC and 1Hz over the right DLPFC，Interval of 5 minutes each side.During rTMS blocks, the coil will be oriented tangential to the surface. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
left DLPFC sham and right DLPFC active treatment group
ACTIVE COMPARATOREach patient will be given 5 treatment sessions per week for 2 weeks (a total of 10 sessions).In each rTMS conditioning session,1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left and rigt DLPFC.Each session is 45 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC and 1Hz over the right DLPFC，Interval of 5 minutes each side.During rTMS blocks, the coil will be oriented tangential to the surface. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
left DLPFC sham and right DLPFC sham treatment group
SHAM COMPARATOREach patient will be given 5 treatment sessions per week for 2 weeks (a total of 10 sessions).In each rTMS conditioning session,1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left and rigt DLPFC.Each session is 45 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC and 1Hz over the right DLPFC，Interval of 5 minutes each side.During rTMS blocks,the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
Interventions
Each patient will be given 5 treatment sessions per week for 2 weeks (a total of 10 sessions).In each rTMS conditioning session,1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left and rigt DLPFC.Each session is 45 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC and 1Hz over the right DLPFC，Interval of 5 minutes each side.During rTMS blocks, the coil will be oriented tangential to the surface. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old and ≤ 80 years old, male or female
- Subjects with idiopathic PD (according to Movement Disorder Society Clinical Diagnostic Criteria，both clinically established PD and clinically probable PD)
- Subjects fulfilling the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition(DSM-IV)
- Did not use antidepressant(s) for a minimum of 2 months
- Untreated or had stabilized doses of anti-Parkinson's disease medication for \> 28 days, and maintain this dose during treatment
- Subjects or their legal representatives could follow the research plan, visit plan
- Subjects or their legal guardians agree to participate in the trial and signs informed consent
You may not qualify if:
- Subjects with Parkinson's plus syndrome(PPS) or Secondary Parkinson Disease caused by vascular factors, toxins, and drugs
- Subjects with persistent head tremor
- Subjects with dementia
- Subjects with suicidal tendency and psychotic symptoms
- Subjects with consciousness, history of stroke, severe neurological/psychiatric disorders such as transient ischemic attack within 1 year prior to screening (Visit 1), or other severe organic diseases
- Accepted deep brain stimulation(DBS) or other invasive brain surgery previously
- Subjects with contraindications for repetitive transcranial magnetic stimulation(rTMS), such as history of epileptic seizures, pregnant, implantation of pacemaker or other metal implants in the body, intracranial hypertension, severe hemorrhagic tendency, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Related Publications (3)
Brys M, Fox MD, Agarwal S, Biagioni M, Dacpano G, Kumar P, Pirraglia E, Chen R, Wu A, Fernandez H, Wagle Shukla A, Lou JS, Gray Z, Simon DK, Di Rocco A, Pascual-Leone A. Multifocal repetitive TMS for motor and mood symptoms of Parkinson disease: A randomized trial. Neurology. 2016 Nov 1;87(18):1907-1915. doi: 10.1212/WNL.0000000000003279. Epub 2016 Oct 5.
PMID: 27708129RESULTKojovic M, Kassavetis P, Bologna M, Parees I, Rubio-Agusti I, Berardelli A, Edwards MJ, Rothwell JC, Bhatia KP. Transcranial magnetic stimulation follow-up study in early Parkinson's disease: A decline in compensation with disease progression? Mov Disord. 2015 Jul;30(8):1098-106. doi: 10.1002/mds.26167. Epub 2015 Mar 5.
PMID: 25753906RESULTDagan M, Herman T, Mirelman A, Giladi N, Hausdorff JM. The role of the prefrontal cortex in freezing of gait in Parkinson's disease: insights from a deep repetitive transcranial magnetic stimulation exploratory study. Exp Brain Res. 2017 Aug;235(8):2463-2472. doi: 10.1007/s00221-017-4981-9. Epub 2017 May 16.
PMID: 28509934RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lijuan Wang, Ph.D
Guangdong Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2018
First Posted
June 12, 2018
Study Start
August 15, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
January 13, 2021
Record last verified: 2020-07