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

N/ANot Yet RecruitingNCT07534397

The University of Texas at Dallas20 enrolled

Overview

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 by our group, under which the pre-supplementary motor area (preSMA) of the dorsomedial frontal lobes play an important role, we propose to treat 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, we are also exploring 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

PARKINSON DISEASE (Disorder)

Interventions

transcranial direct current stimulationDEVICE

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

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with PD having a verbal fluency deficit * 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 confounding psychological or neurological disorder, including, epilepsy or other seizure disorders; severe traumatic brain injury (based on the Ohio State TBI Identification Method); brain tumor; stroke; present drug abuse/misuse; or Huntington's disease. Participants being seen in the PIs clinics will be assessed for these issues as a part of the standard clinical assessment. * Additionally, exclusion criteria include cranial implants or skull defects that affect tDCS administration; and use of medications that interact with or potentially interact with tDCS effects, including, anti-convulsants, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole, or citalopram * Patients with a diagnosis of just dysarthria or who have a deep brain stimulation (DBS) device will be excluded. * Additionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English. * Individuals with cognitive impairment, as indicated by a score of 22 or less on the Montreal Cognitive Assessment, will be considered for exclusion due the concern of a reduced ability to consent. Participants with a score of 22 or less will only be able to participate if they have an accompanying study partner/caregiver with them and we can obtain the written consent of both the participant and the participant's accompanying study partner/caregiver who will be the participant's spouse, adult child, parent, or adult sibling. If they do not have an accompanying study partner/caregiver, they will not be allowed to participate at that time. However, they will be allowed to come back at a later date with an accompanying study partner/caregiver and move forward with the consent procedures and study as above.

Outcomes

Primary Outcomes

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

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

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 COWAT Phonemic Fluency

Evaluation of treatment group differences in change on COWAT Phonemic Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated

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 COWAT Phonemic Fluency

Evaluation of treatment group differences in change on COWAT Phonemic Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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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 difference in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during a reading passage.

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.

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 difference in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during self-generated speech.

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 MDS-UPDRS Part III score.

Evaluation of treatment group differences in change in MDS-UPDRS Part III score from baseline to 1-week post-treatment. Metric: MDS-UPDRS Part III score.

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 MDS-UPDRS Part III score.

Evaluation of treatment group differences in change in MDS-UPDRS Part III score from baseline to 2-month post-treatment. Metric: MDS-UPDRS Part III score.

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.

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 difference in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during a reading passage.

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.

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 difference in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech.

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.

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 difference 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.

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.

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 difference 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.

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.

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.

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