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.
1 other identifier
interventional
12
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
2 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
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 20, 2010
CompletedFirst Posted
Study publicly available on registry
April 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 24, 2020
April 1, 2020
3.2 years
April 20, 2010
April 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of improvement in general motor functioning in patients with Parkinson's.
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 Outcomes (1)
Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's.
after treatment (10 days) and at follow up (1 and 2 months after final stimulation)
Study Arms (4)
Left active anodal DLPFC
EXPERIMENTALWe 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).
Right active anodal DLPFC
EXPERIMENTALWe 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).
Sham tDCS
PLACEBO COMPARATORSham tDCS: For sham-controlled tDCS subjects, the same montage will be used; however current will be applied for only 30 seconds.
Open-Label Arm
OTHERIn 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114, United States
Berenson Allen Center for Noninvasive Brain Stimulation
Boston, Massachusetts, 02125, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Fregni, MD, PhD
Spaulding Rehabilitation Hospital
- STUDY CHAIR
Ross Zafonte, DO
Spaulding Rehabilitation Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 20, 2010
First Posted
April 29, 2010
Study Start
December 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 24, 2020
Record last verified: 2020-04