Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with movement deficits, such as Parkinson's disease and chronic stroke. However, the effects of tDCS have so far not been proven on a wider scale due to lack of knowledge regarding exactly how tDCS works. This has limited the adoption of this potentially useful therapy for patients with Parkinson's disease, chronic stroke and other conditions affecting movement. The investigators hypothesize that by studying the effects of tDCS in subjects performing a motor task, the brain signals mediating improvements in motor control will be identified. The investigators will use both noninvasive and invasive methods to explore this hypothesis. The investigators expect this combined approach to broaden understanding of tDCS application in conditions affecting movement and possibly lead to therapeutic advances in these populations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation (invasive recording) | Patients with Parkinson's disease undergoing surgery for deep brain stimulation will be studied using electrocorticography combined with transcranial direct current stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation (invasive recording) | Device | Subjects are brought into the operating room. The scalp is prepped with a sterilizing solution. Following infiltration with local anesthetic and incision, a 6-contact electrocorticography strip is inserted into the burr hole covering primary motor cortex. Electrocorticography strip terminals are connected to an amplifier for signal recording. Gas-sterilized transcranial direct current stimulation electrodes are placed on the scalp directly overlying primary motor cortex. tDCS electrodes are connected to a low-current generator. During electrocorticographic recording, stimulation is turned on while subjects are asked to flex each arm. At the conclusion of the experiment, the electrocorticography strip and tDCS electrodes are removed and the surgery proceeds as planned. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Primary Motor Cortex Beta-Band Spectral Power During Movement Preparation With Anodal tDCS | Primary motor cortex (PriMC) beta-band (13-30 Hz) spectral power was measured using subdural electrocorticography (sECoG) in patients with Parkinson's disease undergoing deep brain stimulation surgery. Spectral power was analyzed during the movement preparation phase of a cued arm-reaching task. The outcome represents the change in beta-band spectral power during anodal transcranial direct current stimulation (tDCS) relative to pre-stimulation baseline, averaged across task trials for each participant. | Intraoperative assessment during deep brain stimulation surgery: baseline (pre-tDCS) and during anodal tDCS; change from baseline during movement preparation reported. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
patients with parkinson's disease
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathan C Rowland, MD,PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stimulation (Invasive Recording) | Patients with Parkinson's disease undergoing surgery for deep brain stimulation will be studied using electrocorticography combined with transcranial direct current stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stimulation (Invasive Recording) | Patients with Parkinson's disease undergoing surgery for deep brain stimulation will be studied using electrocorticography combined with transcranial direct current stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Primary Motor Cortex Beta-Band Spectral Power During Movement Preparation With Anodal tDCS | Primary motor cortex (PriMC) beta-band (13-30 Hz) spectral power was measured using subdural electrocorticography (sECoG) in patients with Parkinson's disease undergoing deep brain stimulation surgery. Spectral power was analyzed during the movement preparation phase of a cued arm-reaching task. The outcome represents the change in beta-band spectral power during anodal transcranial direct current stimulation (tDCS) relative to pre-stimulation baseline, averaged across task trials for each participant. | All enrolled participants with analyzable intraoperative sECoG data. | Posted | Mean | Standard Deviation | log10(µV²/Hz) | Intraoperative assessment during deep brain stimulation surgery: baseline (pre-tDCS) and during anodal tDCS; change from baseline during movement preparation reported. |
|
from enrollment until end of follow-up, up to 4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stimulation (Invasive Recording) | Patients with Parkinson's disease undergoing surgery for deep brain stimulation will be studied using electrocorticography combined with transcranial direct current stimulation |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Attending | Medical University of South Carolina | 8437927700 | rowlandn@musc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2019 | Mar 20, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2019 | Mar 16, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Patients with Parkinson's disease undergoing surgery for deep brain stimulation will be studied using electrocorticography combined with transcranial direct current stimulation
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |