Anyone hear or know this trial I found that's being done ?

Use of Noninvasive Brain Stimulation in Parkinson's Disease

[shall1019]

I haven't but the idea of it sounds great.

[Jash]

The University of Virginia Medical Department of Neurosurgery has pioneered focused Ultasound Therapy for Essential Tremor. There was an impressive clip on the ABC Evening News with Diane Sawyer last January. There's a link to it on UVAs Department of Neurosurgery web page. I discussed with my neuro; she knew about it but said it had not been tried for PD at the time and that, unlike DBS, it is not reversible. I went ahead in June with DBS.

[PatV]

I also read about a magnetic resonance for PD. I'll keep an eye open for it.

[Hidden]

Trial record 49 of 1023 for:    Parkinson's

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Use of Noninvasive Brain Stimulation in Parkinson's Disease

This study is currently recruiting participants.

Verified August 2012 by Spaulding Rehabilitation Hospital

Sponsor:

Spaulding Rehabilitation Hospital

Information provided by (Responsible Party):

Felipe Fregni, Spaulding Rehabilitation Hospital

ClinicalTrials.gov Identifier:

NCT01113086

First received: April 20, 2010

Last updated: August 17, 2012

Last verified: August 2012

History of Changes

Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record

  Purpose

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.

Condition Intervention Phase

Parkinson's Disease

Device: Transcranial direct current stimulation

Phase 1

Study Type: Interventional

Study Design: Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Crossover Assignment

Masking: Double Blind (Subject, Outcomes Assessor)

Primary Purpose: Basic Science

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Perry syndrome

MedlinePlus related topics: Parkinson's Disease Rehabilitation

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

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 Outcome Measures:

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) ] [ Designated as safety issue: No ]

Will be measured by The Stroop Test, Hooper Visual Organization Test, Digit Span Test, Trail Making Test B.

Estimated Enrollment: 66

Study Start Date: December 2009

Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions

Experimental: 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).

Device: 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).

Other Name: tDCS, direct current stimulation

Experimental: 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).

Device: 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).

Other Name: tDCS, direct current stimulation

Placebo Comparator: Sham tDCS

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

Device: 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).

Other Name: tDCS, direct current stimulation

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.

Device: 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).

Other Name: tDCS, direct current stimulation

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

Ages Eligible for Study:   40 Years to 90 Years

Genders Eligible for Study:   Both

Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113086

Contacts

Contact: Kayleen M Weaver, BA 617 573 2196 [e-mail]

Contact: Felipe Fregni, MD 617 573 2326 [e-mail]

Locations

United States, Massachusetts

Spaulding Rehabilitation Hospital Recruiting

Boston, Massachusetts, United States, 02114

Contact: Kayleen M Weaver, BA     617-573-2196     [e-mail]    

Contact: Felipe Fregni, MD, PhD     617-573-2326     [e-mail]    

Berenson Allen Center for Noninvasive Brain Stimulation Recruiting

Boston, Massachusetts, United States, 02125

Contact: Jennifer Perez, BS     617-667-0226     [e-mail]    

Contact: Alvaro Pascual-Leone, MD, PhD     (617) 667 - 0203     [e-mail]    

Sponsors and Collaborators

Spaulding Rehabilitation Hospital

Investigators

Principal Investigator: Felipe Fregni, MD, PhD Spaulding Rehabilitation Hospital

Study Chair: Ross Zafonte, DO Spaulding Rehabilitation Hospital

  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital

ClinicalTrials.gov Identifier: NCT01113086     History of Changes

Other Study ID Numbers: 2009-P-001806

Study First Received: April 20, 2010

Last Updated: August 17, 2012

Health Authority: United States: Food and Drug Administration

Keywords provided by Spaulding Rehabilitation Hospital:

Parkinson

Transcranial direct current stimulation

Motor function

Cognitive function

Affective function

Additional relevant MeSH terms:

Parkinson Disease

Parkinsonian Disorders

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

Movement Disorders

Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 20, 2012

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[Hidden in reply to Hidden]

This is it I don't qualify for this but for you do give it a shot !

Good luck

God speed