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PARKINSON DISEASE (Disorder)NCT07534397

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

A study testing transcranial direct current stimulation in people with PARKINSON DISEASE (Disorder), run by The University of Texas at Dallas at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
PARKINSON DISEASE (Disorder)
What is being tested?
transcranial direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
15 Sep 2026to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 36Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Callier Clinical Center, The University of Texas at Dallas

    Richardson, Texas, 75080

Other trials in United States

About this study

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).

Read the detailed description

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:

  1. Examine the therapeutic effects on verbal retrieval function by modulating the preSMA using HD tDCS.
  2. Examine the therapeutic effects on speech production and processing by modulating the preSMA using HD tDCS
  3. Examine the therapeutic effects on gait and balance by modulating the preSMA using HD tDCS

Hypotheses:

  1. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve verbal fluency (i.e, phonemic and category fluency on Controlled Word Association Test) as primary outcome measures.
  2. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve speech sequencing.
  3. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve general motor sequencing
Being tested
transcranial direct current stimulation, Sham transcranial direct current stimulation
Keywords
transcranial direct current stimulation (tDCS), Parkinson's Disease, electroencephalography (EEG), presupplementary motor area (preSMA), verbal memory, speech sequencing, motor sequencing
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial direct current stimulationDevice

    Also called transcranial electric stimulation, tDCS, tES

    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 stimulationDevice

    Also called sham tDCS, Sham trascranial electric stimulation, sham 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.

Study groups in NCT07534397
Study groupRoleWhat they receive
Transcranial direct current stimulationExperimentalTranscranial 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
Receives: Device: transcranial direct current stimulation
Sham transcranial direct current stimulationSham comparatorSham 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.
Receives: Device: Sham transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  2. 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)

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

  3. 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)

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  4. 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)

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

Secondary outcomes (16)
  1. 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).

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  2. 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).

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  3. 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).

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  4. 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).

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  5. 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)

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  6. 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)

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

  7. 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).

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  8. 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).

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  9. 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).

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  10. 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).

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  11. 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%).

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  12. 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%).

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  13. 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%).

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  14. 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%).

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  15. 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).

    Measured: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  16. 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).

    Measured: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start15 Sep 2026
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants with PD will be randomly assigned to receive 10-sessions of either active tDCS at 1 mA targeting pre-SMA or sham. Stimulation (1 mA anodal) will target the presupplementary motor area (preSMA) for 20 minutes over 10 sessions. Hypothesis (1): Active HD tDCS will improve language function for verbal output and word finding (primary outcomes) will be Controlled Oral Word Association Test (COWAT) letter fluency, category fluency, and visual confrontation naming speed. Hypotheses (2): Active HD tDCS will improve from baseline speech rate / rhythm (i.e., mean speaking rate and coefficient of variation of syllable duration during speaking tasks) as secondary outcome measures post intervention. Hypotheses (3): Active HD tDCS will improve from baseline gait/freezing of gait metrics as secondary outcome measures post intervention.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07534397
Sponsor's protocol ID
IRB-26-35
Status last verified
Nov 2026
First submitted
9 Apr 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation in people with PARKINSON DISEASE (Disorder), run by The University of Texas at Dallas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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