NCT00082342

Brief Summary

This study will examine the effects of transcranial direct current stimulation (tDCS) on gait (walking) problems and rigidity in patients with Parkinson's disease. tDCS is a method of brain stimulation that may be able to change the electrical activity of the nerves of the brain, possibly causing Parkinson's disease symptoms to improve. Patients between 40 and 80 years of age with moderately severe Parkinson's disease whose main symptoms are problems with walking, including freezing, or rigidity, may be eligible for this study. Candidates must be taking Sinemet or another L-DOPA drug and not have too much tremor. Participants will be assigned to receive either real or sham (placebo) tDCS. Both groups will have eight treatments over 3-1/2 weeks. For the tDCS, electrodes are placed on wet pads on the scalp. An electrical current passes through the electrodes, travels through the scalp and skull, and causes small electrical currents in the cortex-the outer part of the brain. Participants will have a neurological examination, including an evaluation of walking, just before and just after each tDCS session. Patients' motor function will be re-evaluated at 1, 3, and 6 months after the last tDCS treatment. ...

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

May 6, 2004

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

December 27, 2012

Completed
Last Updated

December 27, 2012

Status Verified

November 1, 2012

Enrollment Period

5.9 years

First QC Date

May 6, 2004

Results QC Date

August 31, 2012

Last Update Submit

November 22, 2012

Conditions

Parkinson Disease

Keywords

Human BrainElectrical StimulationParkinson DiseasePD

Outcome Measures

Primary Outcomes (1)

  • Gait Speed Before and After Real and Sham tDCS.

    Gait speed was measured by the time it took the subject to walk 10m. Subjects were instructed to walk at a fast pace without taking the risk of falling, wearing the same shoes and using assistive devices consistently if needed. Gait speed was measured at baseline and post-tDCS.

    baseline, 1 day post, 1 month post, 3 months post-tDCS

Secondary Outcomes (3)

  • UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.

    baseline, 1 day post, 1 month post, 3 months post-tDCS

  • UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.

    baseline, 1 day post, 1 month post, and 3 months post real and sham tDCS

  • Bradykinesia Measure Before and After Real and Sham tDCS.

    baseline, 1 day post, 1 month post, 3 months post tDCS

Study Arms (2)

real transcranial direct current stimulation (tDCS)

ACTIVE COMPARATOR
Device: Phoressor II (IOMED)

sham transcranial direct current stimulation (tDCS)

SHAM COMPARATOR
Device: Phoressor II (IOMED)

Interventions

Phoressor II (IOMED)DEVICE

sham stimulation

sham transcranial direct current stimulation (tDCS)

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be men and women aged 40-80 years with DOPA-responsive, akinetic-rigid PD.
  • Patients who have never participated in HMCS protocols for PD will be interviewed and examined by either the principal investigator or a physician from the Brain Stimulation Unit or HMCS in order to establish the diagnosis of PD and rule out any neurological condition. Only patients with a Hoehm and Yahr grade of 2 to 4 while "off" will be accepted.
  • Patients must be on a regimen including levodopa. The total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 375 milligrams per day. Other anti-parkinsonian medications are also acceptable.
  • Patients should have problems with walking, including freezing, so that their gait time for a 10-meter distance will be six seconds or more.

You may not qualify if:

  • Patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness will also be excluded.
  • Patients unable to walk a 10-meter distance will be excluded.
  • Mentally impaired patients having no capacity to provide their own consent will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

  • Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7. doi: 10.1097/00006123-198701000-00030.

    PMID: 3808255BACKGROUND

  • Antal A, Nitsche MA, Paulus W. External modulation of visual perception in humans. Neuroreport. 2001 Nov 16;12(16):3553-5. doi: 10.1097/00001756-200111160-00036.

    PMID: 11733710BACKGROUND

  • Braun BL. Treatment of an acute anterior disk displacement in the temporomandibular joint. A case report. Phys Ther. 1987 Aug;67(8):1234-6. doi: 10.1093/ptj/67.8.1234.

    PMID: 3615594BACKGROUND

  • Benninger DH, Lomarev M, Lopez G, Wassermann EM, Li X, Considine E, Hallett M. Transcranial direct current stimulation for the treatment of Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1105-11. doi: 10.1136/jnnp.2009.202556.

    PMID: 20870863DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Mark Hallett, MD, Chief
Organization
NINDS, NIH
hallettm@ninds.nih.gov
301-496-9526

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2004

First Posted

May 6, 2004

Study Start

March 1, 2003

Primary Completion

February 1, 2009

Last Updated

December 27, 2012

Results First Posted

December 27, 2012

Record last verified: 2012-11

Locations

US(1)