Callier Clinical Center, The University of Texas at Dallas
Richardson, Texas, 75080, United States
Location contact
John Hart, Jr, MD
PRINCIPAL_INVESTIGATOR
Michael A Motes, PhD
CONTACT
Saul A Frankford, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07534397
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).
Trial opening soon.
Get Notified50 year–90 year
All sexes
Interventional
Not applicable
Richardson, Texas, 75080, United States
John Hart, Jr, MD
PRINCIPAL_INVESTIGATOR
Michael A Motes, PhD
CONTACT
Saul A Frankford, PhD
PRINCIPAL_INVESTIGATOR
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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: 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.
Other names: sham tDCS, Sham trascranial electric stimulation, sham tES
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)
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)
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)
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)
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 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 13 weeks: change from baseline to 2-months Post-Treatment
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 6 weeks: Change from baseline to 1-week Post-Treatment
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 13 weeks: change from baseline to 2-months Post-Treatment
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 6 weeks: Change from baseline to 1-week Post-Treatment
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 13 weeks: Change from baseline to 2-month Post-Treatment
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 6 weeks: Change from baseline to 1-week Post-Treatment
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 13 weeks: change from baseline to 2-months Post-Treatment
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 6 weeks: Change from baseline to 1-week Post-Treatment
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 13 weeks: change from baseline to 2-months Post-Treatment
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 6 weeks: Change from baseline to 1-week Post-Treatment
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 13 weeks: change from baseline to 2-months Post-Treatment
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 6 weeks: Change from baseline to 1-week Post-Treatment
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 13 weeks: change from baseline to 2-months Post-Treatment
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 6 weeks: Change from baseline to 1-week Post-Treatment
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 13 weeks: Change from baseline to 2-month Post-Treatment
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).
Contact information is provided by the study sponsor or research team.
The University of Texas at Dallas
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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