NCT07534397 · The University of Texas at Dallas
Treatment of Cognitive and Sensorimotor Deficits in Parkinson's Disease With High Definition Transcranial Direct Current Stimulation
What this study is about
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).
View original scientific description
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).
Interventions
DEVICE
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.
DEVICE
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 measures
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
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)
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
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)
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
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)
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
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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;
- 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;
- 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.
Where
- Richardson, Texas
Collaborators
University of Texas Southwestern Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2026 · Source of record for eligibility and locations