Use of Noninvasive Brain Stimulation in Parkinson's Disease

Mass General Brigham

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01113086

2009-P-001806

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 4 patient groups, including a placebo group

Left active anodal DLPFC

Experimental group

Description:

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).

Treatment:

Device: Transcranial direct current stimulation

Right active anodal DLPFC

Experimental group

Description:

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).

Treatment:

Device: Transcranial direct current stimulation

Sham tDCS

Placebo Comparator group

Description:

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

Treatment:

Device: Transcranial direct current stimulation

Open-Label Arm

Other group

Description:

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.

Treatment:

Device: Transcranial direct current stimulation