An interventional study of transcranial direct current stimulation and Sham transcranial direct current stimulation in PARKINSON DISEASE (Disorder), sponsored by The University of Texas at Dallas. Recruiting at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment
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).
Objective: Based on models of semantic memory retrieval developed, under which the pre-supplementary motor area (preSMA) of the dorsomedial frontal lobes play an important role, the study will examine the treatment of cognitive deficits in PD with HD tDCS applied to the preSMA to improve function in neural circuits supporting verbal retrieval. In addition, as the preSMA is implicated in motor planning and sequencing, the study also will explore whether HD tDCS applied to the preSMA will have an effect on speech and gait.
Specific Aims:
Hypotheses:
Exclusion Criteria:
A potentially study-confounding, tDCS-contraindicated, or EEG-contraindicated psychological, neuropsychiatric, neurological, or other medical issues:
Use of medications that interact with or potentially interact with tDCS or EEG effects:
Additionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English.
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
Device: 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.
Device: Sham 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.
Also known as: transcranial electric stimulation, tDCS, tES
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.
Also known as: sham tDCS, Sham trascranial electric stimulation, sham tES
Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency
valuation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
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
Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
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
Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
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
Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during overt reading
Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment. Metric: syllables per second on a passage reading task (minimum=0; no maximum).
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 Speaking Rate during overt reading
Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during a reading passage (minimum=0; no maximum).
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during self-generated speech
Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment. Metric: Syllables per second during self-generated speech (minimum=0; no maximum).
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 Speaking Rate during self-generated speech
Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during self-generated speech (minimum=0; no maximum).
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.
Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 1-week post-treatment. Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)
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-month Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.
Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 2-month post-treatment. Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)
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 Speaking Rhythm during overt reading
Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment. Metric: coefficient of variation of syllable duration on a passage reading task (minimum=0; no maximum).
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 Speaking Rhythm during overt reading
Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during a reading passage (minimum=0; no maximum).
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during self-generated speech
Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).
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 Speaking Rhythm during self-generated speech
Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during overt reading
Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment. Metric: Pause time as percentage of total speaking time on a passage reading task (minimum=0%; maximum=100%).
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 Speaking Pause Time during overt reading
Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment. Metric: Pause time as percentage of total speaking time during a reading passage (minimum=0%; maximum=100%).
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during self-generated speech
Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment. Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).
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 Speaking Pause Time during self-generated speech
Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment. Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment
Treatment group differences in change from Baseline to 1-week Post-treatment on Freezing of Gate during the timed up and go task
Evaluation of treatment group differences in change in freezing of gate from baseline to 1-week post-treatment. Metric: Timed up and go time (minimum=0; no maximum).
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-month Post-treatment on Freezing of Gate during the timed up and go task
Evaluation of treatment group differences in change in freezing of gate from baseline to 2-month post-treatment. Metric: Timed up and go time (minimum=0; no maximum).
Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in published articles, including baseline demographic and clinical characteristics required to replicate the findings, will be made available.
Supporting information: Study protocol, Sap
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