Clinical trial NCT04759898: Direct Measurement of Motor Cortical Responses to tDCS
Official title: Direct Measurement of Motor Cortical Responses to Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Chronic Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the first arm, Parkinson's disease and chronic stroke subjects will be investigated using noninvasive methods, including EEG and tDCS, respectively. In the second arm, a separate cohort of Parkinson's disease and chronic stroke subjects will be investigated using noninvasive methods, including EEG and sham tDCS, respectively. In the third arm, patients with Parkinson's disease will be investigated using electrocorticography (while undergoing surgery for deep brain stimulation) combined with tDCS.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in primary motor cortical (PriMC) beta oscillations during cued arm reaching in relation to anodal tDCS activation
timeFrame: Subjects will undergo baseline EEG recording 5 min before tDCS starts, during tDCS (5 min after stimulation starts) and 5 min after tDCS stimulation ends. Measurements will be made similarly during sham stimulation.
measure: Change in primary motor cortical (PriMC) beta oscillations during arm flexion in relation to anodal tDCS activation
timeFrame: Subjects will undergo baseline ECoG recording 5 min before tDCS starts, during tDCS (5 min after stimulation starts) and 5 min after tDCS stimulation ends. Measurements will be made similarly during sham stimulation.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Nathan C Rowland, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: