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Official Study Title: Selective Modulation of Cognitive,  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. Affective, and Motor Function by Transcranial Direct Current Stimulation as Co-Adjuvant Therapy  TherapyAnother word for “treatment”. in Parkinson’s Disease
Sponsor: Robert P. and Judith N. Goldberg Foundation (RJG)
Clinicaltrials.gov ID: NCT01113086
Study ID: 2009-P-001806

Summary

The purpose of this research is to determine whether repetitive sessions of sending a weak electrical current through the scalp to the brain (using a non-invasive technique called transcranial direct current stimulation or tDCS), can enhance the cognitive, affective and motor functioning of those with Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms.

In this study investigators will compare people who receive tDCS with those who receive a placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. (fake) tDCS. Each person 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 Phase

Phase 1
What is a study phase?

Symptoms Addressed: Movement and Non-movement

Walking/Gait,  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. Tremor,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Memory, Loss of Motor Skills, Cognitive Moods, Anxiety

Time Commitment

• Less than one month
• Ten stimulation sessions on consecutive days, Monday through Friday, for a total of two weeks. Visits are one to two hours long.

Eligibility

• Minimum Age: 40
• Gender(s) Accepted: Either
• Minimum Years Since Diagnosis: 1

Inclusion Criteria

• Diagnosis of “probable” PD, defined by the presence of at least two out of three motor features of PD (resting tremor,  Resting TremorA tremor of a limb that increases when the limb is at rest. rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment)
• Taking stable medications for at least 30 days

Exclusion Criteria

• Features suggestive of other causes of Parkinsonism syndromes
• History of deep brain stimulation  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. or surgery to remove brain lesions
• History of schizophrenia, schizoaffective disorder, other psychosis,  PsychosisA loss of contact with reality often accompanied by hallucinations. Psychosis can be caused by some PD medications and is more common in patients with advanced Parkinson's. bipolar illness, alcohol/drug abuse within the past year
• Need for rapid clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. response due to conditions such as psychosis or suicidality
• Contraindications to tDCS such as metal in the head or implanted brain medical devices
• Unstable medical conditions (e.g. uncontrolled diabetes, heart issues, heart failure, or lung issues)
• Pregnancy

Enrollment

Expected Enrollment: 66 (US)
Date Enrollment Began: May 2010
Date Enrollment Ends: Dec 2012
Last Updated Date: Aug 19 2010
Trial Post Date: May 11 2010
Website: http://www.clinicaltrials.gov/ct2/show/NCT01113086

Primary Contacts and Locations

Massachusetts

• Laura Sherman, B.A.
  Spaulding Rehabilitation Hospital
  lsherman@neuromodulationlab.org
  Phone: (617) 573-2499
  125 Nashua Street
  Room 726
  Boston, MA 02114
  USA
  
• Kayleen Weaver
  Spaulding Rehabilitation Hospital
  kmweaver@partners.org
  Phone: (617) 573-2196
  125 Nashua Street
  Room 726
  Boston, MA 02114
  USA
  

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