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

NCT07534397 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB-26-35
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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)

  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)

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

Secondary Outcomes (16)

• Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during overt reading

  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

  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

  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

  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.

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

Study Arms (2)

Transcranial direct current stimulation

EXPERIMENTAL

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

SHAM COMPARATOR

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

Interventions

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.

Also known as: sham tDCS, Sham trascranial electric stimulation, sham tES

Sham transcranial direct current stimulation

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.

Also known as: transcranial electric stimulation, tDCS, tES

Transcranial direct current stimulation

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years old
• Capable of understanding and signing an informed consent (able to answer consent comprehension questions)
• Fluent in speaking and reading English

You may not qualify if:

• 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;

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

Callier Clinical Center, The University of Texas at Dallas

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• John Hart, MD

  Callier Clinical Research Center, The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

• Saul A Frankford, PhD

  Callier Clinical Research Center, The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Motes, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, assessors, and technicians interacting with participants will be blind to assigned conditions. The software for the transcranial direct current system allows for maintaining blinds when uploading and running protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 36 months following publication.
• Access Criteria: Access will be provided via email request to the corresponding author or through the designated repository required by the publishing journal.

Locations

US (1)