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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorThe University of Texas at Dallas

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Transcranial direct current stimulationExperimental treatment 1 intervention
Group B: Sham transcranial direct current stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
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)

Time frame
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)

Time frame
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)

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

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).

Time frame
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).

Time frame
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).

Time frame
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).

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

Other outcomes

Sponsors and contacts

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The University of Texas at Dallas

Lead sponsor

University of Texas Southwestern Medical Center

Collaborator