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Clinical Trials/NCT04759898
NCT04759898CompletedNot Applicable

Direct Measurement of Motor Cortical Responses to Transcranial Direct Current Stimulation

Medical University of South Carolina2 sites in 1 country20 target enrollmentStarted: January 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Change in primary motor cortical (PriMC) beta oscillations during cued arm reaching in relation to anodal tDCS activation

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Masking Description

In the first and second arms, prior to placement of electrodes, subjects will be randomized to either treatment or sham. This will occur using a random number generator with a binary choice determination (1 = stimulation; 2 = sham). Patients will be blinded to this choice.

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: transcranial direct current stimulation (invasive recording) (Device)

Outcomes

Primary Outcomes

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 stimulation starts) and 5 min after tDCS stimulation ends. Measurements will be made similarly during sham stimulation.

EEG is used to track beta spectral power during a cued motor task in conjuction with transcranial direct current stimulation or sham

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 stimulation starts) and 5 min after tDCS stimulation ends. Measurements will be made similarly during sham stimulation.

ECoG is used to track beta spectral power during an arm flexion task in conjuction with transcranial direct current stimulation

Change in Primary Motor Cortex Beta-Band Spectral Power During Movement Preparation With Anodal tDCS

Time Frame: Intraoperative assessment during deep brain stimulation surgery: baseline (pre-tDCS) and during anodal tDCS; change from baseline during movement preparation reported.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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