- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01113086
Use of Noninvasive Brain Stimulation in Parkinson's Disease
Selective Modulation of Cognitive, Affective, and Motor Function by Transcranial Direct Current Stimulation as Co-adjuvant Therapy in Parkinson's Disease.
The purpose of this research is to determine whether repetitive sessions of transcranial direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive, affective and motor functioning of those with Parkinson's Disease.
In this study we will compare active tDCS with sham tDCS. Each subject will receive two consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and affective tests will be administered throughout the duration of the study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Note that this study is a two-center study (the other center is Beth Israel Deaconess Medical Center - PI - Alvaro Pascual-Leone)
* Further study details are provided by Spaulding Rehabilitation Hospital.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Spaulding Rehabilitation Hospital
-
Boston, Massachusetts, United States, 02125
- Berenson Allen Center for Noninvasive Brain Stimulation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of "probable" PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment);
- Age 40 or over;
- Taking stable medications for at least 30 days
Exclusion Criteria:
- Features suggestive of other causes of parkinsonism/ parkinson-plus syndromes;
- History of deep brain stimulation or ablation surgery, mass brain lesions;
- History of schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, alcohol/drug abuse within the past year;
- Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
Contraindications to tDCS*
- metal in the head
- implanted brain medical devices
- Unstable medical conditions (eg. uncontrolled diabetes, uncompensated cardiac issues heart failure, pulmonary issues, or chronic obstructive pulmonary disease)
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Left active anodal DLPFC
We will place the anodal electrode on the left dorsolateral prefrontal cortex.
Stimulation will be given at 2 mA for a total of 20 mins for 10 consecutive sessions (Monday through Friday).
|
Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks.
During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other Names:
|
Experimental: Right active anodal DLPFC
We will place the anodal electrode on the right dorsolateral prefrontal cortex.
Stimulation will be given at 2 mA for a total of 20 mins for 10 consecutive sessions (Monday through Friday).
|
Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks.
During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other Names:
|
Placebo Comparator: Sham tDCS
Sham tDCS: For sham-controlled tDCS subjects, the same montage will be used; however current will be applied for only 30 seconds.
|
Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks.
During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other Names:
|
Other: Open-Label Arm
In addition to this study we will have an open label arm in which subjects who received sham stimulation through the course of the study will have the opportunity to receive active stimulation free of charge.
The same parameters and identical procedures as is done in the original study will be used.
Data will be collected as an open label, which will therefore provide additional information.
Data obtained from this open label portion of the study will be kept separate.
|
Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks.
During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of improvement in general motor functioning in patients with Parkinson's.
Time Frame: after treatment (10 days) and at follow up (1 and 2 months after final stimulation)
|
Measured by various indexes, including Unified Parkinson's Disease Rating Scale (UPDRS), Simple Reaction Time, 4-Choice Reaction Time, Purdue Pegboard Test, Finger tapping, walking time, buttoning up and supination-pronation.
|
after treatment (10 days) and at follow up (1 and 2 months after final stimulation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's.
Time Frame: after treatment (10 days) and at follow up (1 and 2 months after final stimulation)
|
Will be measured by The Stroop Test, Hooper Visual Organization Test, Digit Span Test, Trail Making Test B.
|
after treatment (10 days) and at follow up (1 and 2 months after final stimulation)
|
Collaborators and Investigators
Investigators
- Study Chair: Ross Zafonte, DO, Spaulding Rehabilitation Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
Other Study ID Numbers
- 2009-P-001806
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.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
Shanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIdiopathic Parkinson's DiseaseChina
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
AbbVieActive, not recruitingParkinson's Disease (PD)United States, Australia
-
AbbVieCompletedParkinson's Disease (PD)United States, Australia
-
BlueRock TherapeuticsMemorial Sloan Kettering Cancer CenterActive, not recruitingAdvanced Parkinson's DiseaseUnited States, Canada
Clinical Trials on Transcranial direct current stimulation
-
Federal University of ParaíbaCompleted
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
University of Campinas, BrazilUnknownEpilepsy IntractableBrazil
-
Dina Hatem ElhammadyUnknown
-
Shirley Ryan AbilityLabNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Nonfluent AphasiaUnited States
-
University of Texas Rio Grande ValleyRecruitingSpinal Cord Diseases | Spinal Cord InjuriesUnited States
-
Federal University of ParaíbaUnknown
-
University of CalgaryAlberta Health servicesRecruitingCervicogenic HeadacheCanada
-
Universidade Federal do Rio Grande do NorteNot yet recruitingLow Back Pain | Transcranial Direct Current Stimulation
-
Nanyang Technological UniversityActive, not recruiting