Charleston, South Carolina 29425

  • Chronic Stroke

Purpose:

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.


Criteria:

Inclusion Criteria: - Age 18 or older - Previous consent to be contacted regarding potential participation in a research study at Medical University of South Carolina Exclusion Criteria: - Subjects unable to actively participate in the consent process physically and/or cognitively - Pregnancy - Presence of scalp injury or disease - Prior history of seizures - Metal implants in head or neck - Prior intracranial surgery - Prior brain radiotherapy - Prior history of intracranial tumor, intracranial infection or cerebrovascular malformation


Study is Available At:


Original ID:

00073545


NCT ID:

NCT04759898


Secondary ID:


Study Acronym:


Brief Title:

Direct Measurement of Motor Cortical Responses to tDCS


Official Title:

Direct Measurement of Motor Cortical Responses to Transcranial Direct Current Stimulation


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical University of South Carolina


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Nathan C Rowland, MD,PhD
Principal Investigator
Medical University of South Carolina

Study Dates

Start Date:January 1, 2021
Completion Date:January 1, 2024
Completion Type:Anticipated
Primary Completion Date:January 1, 2024
Primary Completion Type:Anticipated
Verification Date:February 2021
Last Changed Date:February 15, 2021
First Received Date:December 21, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in primary motor cortical (PriMC) beta oscillations during cued arm reaching in relation to anodal tDCS activation
Time Frame:Subjects will undergo baseline EEG recording 5 min before tDCS starts, during tDCS (5 min after stim
Safety Issues:False
Description:EEG is used to track beta spectral power during a cued motor task in conjuction with transcranial direct current stimulation or sham
Outcome Type:Primary Outcome
Measure:Change in primary motor cortical (PriMC) beta oscillations during arm flexion in relation to anodal tDCS activation
Time Frame:Subjects will undergo baseline ECoG recording 5 min before tDCS starts, during tDCS (5 min after sti
Safety Issues:False
Description:ECoG is used to track beta spectral power during an arm flexion task in conjuction with transcranial direct current stimulation

Study Interventions

Intervention Type:Device
Name:transcranial direct current stimulation (noninvasi
Description:Subjects will enter the EEG lab and be seated in a chair. The 26-electrode EEG array will be placed using a conductive paste. The electrodes will be connected to a clinical grade EEG machine used in standard of care routine EEG monitoring. Next, a soft cloth cap will be placed over the subject's head with the tDCS electrodes pre-positioned in place. The cap will be positioned so that the tDCS electrodes cover the scalp without disturbing the underlying EEG electrodes. Conducting gel will be appl
Arm Name:Stimulation (noninvasive recording)
Intervention Type:Device
Name:sham transcranial direct current stimulation (noni
Description:Subjects receiving sham undergo the same setup as the stimulation group with the exception that sham subjects experience stimulation for one minute only (30 second ramp-up to 2 milliamps immediately followed by 30 second ramp-down to 0 milliamps for the remaining 19 minutes). This provides similar sensory feedback to sham subjects that treatment subjects experience. The same electrode array, soft cloth cap, conducting gel application, and lidocaine are applied as in a stimulation subject. The tD
Arm Name:Sham (noninvasive recording)
Intervention Type:Device
Name:transcranial direct current stimulation (invasive
Description: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 conn
Arm Name:Stimulation (invasive recording)

Study Arms

Study Arm Type:Experimental
Arm Name:Stimulation (invasive recording)
Description:Patients with Parkinson's disease undergoing surgery for deep brain stimulation will be studied using electrocorticography combined with transcranial direct current stimulation
Study Arm Type:Sham Comparator
Arm Name:Sham (noninvasive recording)
Description:Patients with Parkinson's disease or chronic stroke will be assigned to undergo EEG recording and sham transcranial direct current stimulation.
Study Arm Type:Active Comparator
Arm Name:Stimulation (noninvasive recording)
Description:Patients with Parkinson's disease or chronic stroke will be assigned to undergo EEG recording and transcranial direct current stimulation.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical University of South Carolina

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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