Clinical trial NCT01113086: Use of Noninvasive Brain Stimulation in Parkinson's Disease
Official title: Selective Modulation of Cognitive, Affective, and Motor Function by Transcranial Direct Current Stimulation as Co-adjuvant Therapy in Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson
Transcranial direct current stimulation
Motor function
Cognitive function
Affective function
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2010-04-29
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Evidence of improvement in general motor functioning in patients with Parkinson's.
timeFrame: after treatment (10 days) and at follow up (1 and 2 months after final stimulation)
Secondary outcomes:
measure: Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's.
timeFrame: after treatment (10 days) and at follow up (1 and 2 months after final stimulation)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: Boston
country: United States
facility: Berenson Allen Center for Noninvasive Brain Stimulation
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spaulding Rehabilitation Hospital
name: Ross Zafonte, DO
role: STUDY_CHAIR
References: