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Completed

NCT Number: NCT01113086

Use of Noninvasive Brain Stimulation 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berenson Allen Center for Noninvasive Brain Stimulation, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

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).

Other names: tDCS, direct current stimulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

Selective Modulation of Cognitive, Affective, and Motor Function by Transcranial Direct Current Stimulation as Co-adjuvant Therapy in Parkinson's Disease.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2010
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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