Standardization and Optimization of TMS Protocols for the Treatment of PD With Depression or Cognitive Impairment
NCT ID: NCT03552861
Last Updated: 2021-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
252 participants
INTERVENTIONAL
2018-08-15
2021-12-31
Brief Summary
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Detailed Description
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The investigators propose to conduct a ten-center, blinded, sham-controlled, randomized, parallel-group study of fixed-dose, high-frequency and/or low-frequency rTMS in 252 PD patients who are experiencing depressive symptoms or cognitive impairment. Subjects will be randomized to receive rTMS over right and left DLPFC, both or neither active/sham rTMS. Subjects will receive rTMS for 45 minutes treatment over a 2-week period, all subjects will undergo a comprehensive assessment of mood, cognition, motor and quality of life before and after the last rTMS treatment, and after 2,4 and 12 weeks post-treatment. This study directly addresses the expansion of rTMS as an alternative treatment for depression and cognitive impairment in the PD population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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left and right DLPFC active treatment
Intervention: 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.
repetitive transcranial magnetic 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. 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 active and right DLPFC sham treatment group
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.
repetitive transcranial magnetic 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. 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
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.
repetitive transcranial magnetic 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. 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
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 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
repetitive transcranial magnetic 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. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
Interventions
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repetitive transcranial magnetic 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. 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
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Inclusion Criteria
2. Subjects with idiopathic PD (according to Movement Disorder Society Clinical Diagnostic Criteria，both clinically established PD and clinically probable PD)
3. Subjects fulfilling the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition(DSM-IV)
4. Did not use antidepressant(s) for a minimum of 2 months
5. Untreated or had stabilized doses of anti-Parkinson's disease medication for \> 28 days, and maintain this dose during treatment
6. Subjects or their legal representatives could follow the research plan, visit plan
7. Subjects or their legal guardians agree to participate in the trial and signs informed consent
Exclusion Criteria
2. Subjects with persistent head tremor
3. Subjects with dementia
4. Subjects with suicidal tendency and psychotic symptoms
5. 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
6. Accepted deep brain stimulation(DBS) or other invasive brain surgery previously
7. 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.
18 Years
80 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Lijuan Wang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Kojovic 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.
Dagan 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.
Other Identifiers
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GDREC2017083H（R1）
Identifier Type: -
Identifier Source: org_study_id
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