Treatment of Cognitive and Sensorimotor Deficits in Parkinson's Disease With High Definition Transcranial Direct Current Stimulation

Part of paid clinical trials in Richardson, Texas.

Sponsor
The University of Texas at Dallas
Study ID
NCT07534397
Status
Not Yet Recruiting

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Conditions

  • PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • transcranial direct current stimulation — DEVICE
    Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
  • Sham transcranial direct current stimulation — DEVICE
    Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

Study Details

The purpose of this research study is to examine the effects of transcranial Direct Current Stimulation (tDCS) on verbal retrieval and cognition and sensorimotor control and to determine if tDCS can be used as a way to improve retrieval, sensory, and motor abilities in individuals with Parkinson's disease (PD).

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcranial direct current stimulation
    Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. Other Names: tDCS 1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10
  • Sham Comparator: Sham transcranial direct current stimulation
    Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

Primary Outcome Measure

Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency [ Time Frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Callier Clinical Center, The University of Texas at DallasRichardsonTexas75080
Michael A Motes, PhD
[email protected]
972-883-4846
John Hart, Jr, MD (PRINCIPAL_INVESTIGATOR)
Saul A Frankford, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Callier Clinical Center, The University of Texas at Dallas· Richardson, TX

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