Use of Noninvasive Brain Stimulation in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: Transcranial direct current stimulation

• Registration Number: NCT01113086
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-29
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham tDCS	Transcranial direct current stimulation	Sham tDCS: For sham-controlled tDCS subjects, the same montage will be used; however current will be applied for only 30 seconds.
Left active anodal DLPFC	Transcranial direct current stimulation	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).
Right active anodal DLPFC	Transcranial direct current stimulation	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).
Open-Label Arm	Transcranial direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
Evidence of improvement in general motor functioning in patients with Parkinson's.	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.

Secondary Outcome Measures

Name	Time	Method
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)	Will be measured by The Stroop Test, Hooper Visual Organization Test, Digit Span Test, Trail Making Test B.

Trial Locations

Locations (2)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States

Berenson Allen Center for Noninvasive Brain Stimulation; 🇺🇸 Boston, Massachusetts, United States