Recruiting

tDCS

Sponsor:

The University of Texas at Dallas

Code:

NCT07534397

Conditions

PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

transcranial direct current stimulation

Sham transcranial direct current stimulation

Study Details

Brief summary:

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).

Conditions

PARKINSON DISEASE (Disorder)

Study ID

NCT07534397

Start date

Sep 15, 2026

Status verified date

Jun, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed with PD having a verbal fluency deficit based on neuropsychological test (T-score < 40 or a T-score <-1.0 SD below the average T-score): Semantic Object Retrieval Test (SORT), COWAT (both letter and category fluency), Boston Naming Test (BNT), Rey Auditory Verbal Learning Test (RAVLT)
  • 50 - 90 years old
  • Capable of understanding and signing an informed consent (able to answer consent comprehension questions)
  • Fluent in speaking and reading English

Exclusion Criteria:

A potentially study-confounding, tDCS-contraindicated, or EEG-contraindicated psychological, neuropsychiatric, neurological, or other medical issues:

  • Montreal Cognitve Assessment (MOCA) score <23, unless an accompanying study partner/caregiver is with them and we can obtain the written consent of both the participant and the participant's accompanying study partner/caregiver (i.e., the participant's spouse, adult child, parent, or adult sibling);
  • history of seizures;
  • unexplained episodes of loss of consciousness (as these may be related to brain alterations or epilepsy);
  • suffering from severe or frequent headaches;
  • unstable or uncontrolled neuropsychiatric illness;
  • severe traumatic brain injury (based on the Ohio State TBI Identification; Method);
  • brain tumor; stroke; present drug abuse/misuse;
  • brain tumor;
  • serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy;
  • Huntington's disease;
  • stroke;
  • cranial implants or skull defects that affect tDCS administration;
  • implanted brain medical devices, including, deep brain stimulators (DBS);
  • implanted pacemakers;
  • any electrically, magnetically, or mechanically activated implants;
  • cardiac, neural, or medication implants;
  • vascular clips or other electrically sensitive support systems in the brain;
  • damaged skin at the sites of stimulation (the device should only be used on healthy, intact skin, as wounds may alter resistance to current);
  • skin conditions such as dermatitis, psoriasis, or eczema;
  • pregnant women;
  • diagnosis of just dysarthria;

Use of medications that interact with or potentially interact with tDCS or EEG effects:

  • anti-convulsants;
  • carbamazepine;
  • sulpiride;
  • pergolide;
  • lorazepam;
  • rivastigmine;
  • dextromethorphan;
  • D-cycloserine;
  • flunarizine;
  • ropinirole;
  • citalopram;
  • stimulants;

Additionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency [ Time Frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment ]
  • Treatment group differences in change from Baseline to 1-week Post-Treatment on Phonemic Fluency [ Time Frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment ]
  • Treatment group differences in change from Baseline to 2-months Post-Treatment on Phonemic Fluency [ Time Frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment ]

Central Contacts and Locations

Central contacts

Michael A Motes, PhD

972-883-4846michael.motes@utdallas.edu

Locations

Callier Clinical Center, The University of Texas at Dallas

Recruiting

Richardson, Texas, United States, 75080

Contacts

Michael A Motes, PhD

972-883-4846michael.motes@utd.edu

Principal Investigator:

John Hart, Jr, MD

More Information

Sponsor

The University of Texas at Dallas

Last update posted

Sep 16, 2026

Last verified

Jun, 2026

Keywords

  • transcranial direct current stimulation (tDCS)
  • Parkinson's Disease
  • electroencephalography (EEG)
  • presupplementary motor area (preSMA)
  • verbal memory
  • speech sequencing
  • motor sequencing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by The University of Texas at Dallas on 2026-09-16.