PARKINSON DISEASE (Disorder)
Conditions
Keywords
transcranial direct current stimulation (tDCS), Parkinson's Disease, electroencephalography (EEG), presupplementary motor area (preSMA), verbal memory, speech sequencing, motor sequencing
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).
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
Interventions
DEVICEtranscranial 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.
DEVICESham 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.
Sponsors
The University of Texas at Dallas
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency | 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 | 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 | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| 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 | 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). |
| 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 | 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). |
| 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 | 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). |
| 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 | 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) |
| 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. | 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) |
| Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during overt reading | 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). |
| Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during overt reading | 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). |
| Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm 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 | 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). |
| Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm 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 | 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). |
| Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during overt reading | 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%). |
| Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during overt reading | 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%). |
| Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time 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 | 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%). |
| Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time 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 | 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%). |
| Treatment group differences in change from Baseline to 1-week Post-treatment on Freezing of Gate during the timed up and go task | 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). |
| Treatment group differences in change from Baseline to 2-month Post-treatment on Freezing of Gate during the timed up and go task | 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). |
Countries
United States
Contacts
CONTACTMichael A Motes, PhD
PRINCIPAL_INVESTIGATORJohn Hart, MD
Callier Clinical Research Center, The University of Texas at Dallas
PRINCIPAL_INVESTIGATORSaul A Frankford, PhD
Callier Clinical Research Center, The University of Texas at Dallas
Outcome results
None listed