Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082342
Status:
COMPLETED
Last Update Posted:
2012-12-27
First Post:
2004-05-06
Brief Title:
Transcranial Direct Current Stimulation to Treat Symptoms of Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Transcranial Direct Current Stimulation for the Treatment of Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of transcranial direct current stimulation tDCS on gait walking problems and rigidity in patients with Parkinsons 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 Parkinsons disease symptoms to improve
Patients between 40 and 80 years of age with moderately severe Parkinsons 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 3-12 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
Patients between 40 and 80 years of age with moderately severe Parkinsons 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 3-12 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
Detailed Description:
The treatment of Parkinsons disease PD needs further improvement particularly in the areas of gait and freezing Transcranial direct current stimulation tDCS which passes weak direct current DC current through the skull and across the cortex has been done for many years with numerous effects described in healthy subjects and patients with mental illness Recently it has been shown by objective means in controlled experiments that this type of treatment has robust and lasting effects on the excitability of the motor cortex in healthy humans We hypothesize that tDCS will have a beneficial effect on gait and freezing in medicated patients and we propose to test this in a controlled trial Specifically we propose to look at the effect of 1-2 mA tDCS with anode position over the frontal poles andor premotor and primary motor cortex and cathode over mastoid process Over a one-year period we will enroll 42 adults with PD and evaluate the acute tDCS effects over a period of four weeks eight tDCS sessions nine visits Additional ratings will be done at one and three months after the end of tDCS sessions Symptoms will be evaluated with standard tests of motor function including the Unified Parkinsons Disease Rating Scale UPDRS and specific tests of gait and freezing We will also look for cumulative long-lasting effects over the three-month period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0116 | None | None | None |