Use of Noninvasive Brain Stimulation in Parkinson's Disease

NCT ID: NCT01113086

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-03-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

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).

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).

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

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).

Sham tDCS

Sham tDCS: For sham-controlled tDCS subjects, the same montage will be used; however current will be applied for only 30 seconds.

Group Type: PLACEBO_COMPARATOR

Transcranial direct current stimulation

Intervention Type: DEVICE

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).

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.

Group Type: OTHER

Transcranial direct current stimulation

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

tDCS, direct current stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Ross Zafonte, DO

Role: STUDY_CHAIR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Berenson Allen Center for Noninvasive Brain Stimulation

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2009-P-001806

Identifier Type: -

Identifier Source: org_study_id