Use of Noninvasive Brain Stimulation in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Selective Modulation of Cognitive, Affective, and Motor Function by Transcranial Direct Current Stimulation as Co-adjuvant Therapy in Parkinson's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113086
• Other study ID #: 2009-P-001806
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Transcranial direct current stimulation
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).

Locations

Country	Name	City	State
United States	Berenson Allen Center for Noninvasive Brain Stimulation	Boston	Massachusetts
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's.	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)