Use of Noninvasive Brain Stimulation in Parkinson's Disease

April 23, 2020 updated by: Felipe Fregni, Spaulding Rehabilitation Hospital

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • tDCS, direct current stimulation
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:
  • tDCS, direct current stimulation
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:
  • tDCS, direct current stimulation
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:
  • tDCS, direct current stimulation

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Ross Zafonte, DO, Spaulding Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 29, 2010

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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