Transcranial Direct Current Stimulation for Cognitive Improvement in Parkinson's Patients (tDCS)

Parkinson Disease Clinical Trial

— tDCS  

Official title:

Transcranial Direct Current Stimulation (tDCS) to Improve Cognitive Function and Cognitive Fatigue in Parkinson's Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03191916
• Other study ID #: SH tDCS Parkinsons
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2015
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: Sanford Health
• Contact: Jessica Keller, B.S.
• Phone: 701-417-5781
• Email: parkinsonsresearch[@]sanfordhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral prefrontal cortex (LDLPFC) will induce long-lasting effects in improving cognitive function and reducing cognitive fatigue and fatigability in PD patients.

Description:

Parkinson's disease (PD) is the second most common neurodegenerative disease (after Alzheimer's disease) and affects approximately one million people in the United States. Mild Cognitive Impairment (MCI) is very common even in early stages of PD. In addition to cognitive impairment, patients with PD also suffer cognitive fatigue (defined as the general sensation of difficulty in initiating cognitive activity) and cognitive fatigability (defined as "deterioration in the performance of attention tasks over an extended period of time"). Cognitive impairment, cognitive fatigue, and cognitive fatigability affect quality of life in patient with Parkinson's disease.

Transcranial direct current stimulation (tDCS) is a noninvasive and safe brain stimulation technique that has been shown to be effective in improving cognitive function in subjects with Parkinson's disease. During tDCS, low-voltage, low amplitude current is passed through a pair of surface electrodes placed over the areas of brain of interest.

The specific aim of this study is to examine if atDCS to LDLPFC at 2 milliamps (mA) for 20 minutes daily for 5 days will improve cognitive function and reduce cognitive fatigue and fatigability in PD patients with MCI. The study will examine if the effects may last for two weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: August 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability)

• Meets criteria for MCI (21 = MOCA scores = 26)

• Must be able to consent

Exclusion Criteria:

• Patients with dementia (MOCA < 21)

• PD treatment using deep brain stimulation (DBS)

• Diagnosis of psychosis

• Diagnosis of multiple sclerosis

• Diagnosis of stroke

• Diagnosis of epilepsy

• Diagnosis of chronic obstructive pulmonary disease

• Diagnosis of congestive heart failure

• Diagnosis of renal failure

• Participants not fluent in English

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• transcranial direct current stimulation
2milliamps will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.
• Sham (for transcranial direct current stimulation)
For 30 seconds the patient will experience a ramp up of the stimulation, after which point no stimulation will be transmitted for the remainder of the session. This will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.

Locations

Country	Name	City	State
United States	Sanford Brain & Spine Center	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14. — View Citation

Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1. — View Citation

Lou JS, Kearns G, Oken B, Sexton G, Nutt J. Exacerbated physical fatigue and mental fatigue in Parkinson's disease. Mov Disord. 2001 Mar;16(2):190-6. doi: 10.1002/mds.1042. — View Citation

Meinzer M, Jahnigen S, Copland DA, Darkow R, Grittner U, Avirame K, Rodriguez AD, Lindenberg R, Floel A. Transcranial direct current stimulation over multiple days improves learning and maintenance of a novel vocabulary. Cortex. 2014 Jan;50:137-47. doi: 10.1016/j.cortex.2013.07.013. Epub 2013 Aug 6. — View Citation

Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Reaction Time (RT) on contextual cueing computer task	A visual search task will be given in which the participant looks for a T among L's. The contextual cuing task will consist of a practice block and forty test blocks. Eight of the trials in a block will consist of search configurations that repeat from block to block (repeat configurations); the other eight trials in a block will be randomly-generated configurations (new configurations). After the final trial, a recognition task will be presented to determine whether participants realized that repeat configurations were presented (not expected; cueing effects appear to result from implicit learning). Reaction time for each block will be recorded, with cognitive fatigue measured as deterioration of RT over the 40 blocks. This measure of change in RT will be compared across the 4 visits (pre-test, 6th visit, 7th visit, and 8th visit). Improved cognition fatigue based on tDCS treatment would predict reduced change in RT in the later visits compared to the pre-test.	90 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session
Secondary	Change in Error Rate on contextual cueing computer task	A visual search task will be given in which the participant looks for a T among L's. The contextual cuing task will consist of a practice block and forty test blocks. Eight of the trials in a block will consist of search configurations that repeat from block to block (repeat configurations); the other eight trials in a block will be randomly-generated configurations (new configurations). After the final trial, a recognition task will be presented to determine whether participants realized that repeat configurations were presented (not expected; cueing effects appear to result from implicit learning). Error rate for each block will be recorded, with cognitive fatigue measured as increased errors over the 40 blocks. This measure of change in error rate will be compared across the 4 visits (pre-test, 6th visit, 7th visit, and 8th visit). Improved cognition fatigue based on tDCS treatment would predict reduced change in error rate in the later visits compared to the pre-test.	90 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session
Secondary	Multidimensional Fatigue Inventory (MFI)	This is a 20-item self-report instrument that measures five dimensions of fatigue independently: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.	5 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session
Secondary	Center for Epidemiological Studies Depression Scale (CES-D)	This is a tool used to screen for symptoms of depression.	5 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session
Secondary	McGill Quality of Life (QOL) Scale	This is a single item tool to assess quality of life on all parts of life (physical, emotional, social, spiritual, and financial.	1 minute; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session
Secondary	Neuropsychological battery (Stroop and Digit Span)	The Stroop Test is a measure of processing speed, attention, and inhibition. In Stroop A, the participant is required to read color words (e.g., Red, Green, etc.) out loud quickly for 45 seconds. In Stroop B, the participant is required to name ink colors out loud as quickly as possible for 45 seconds. In Stroop C, the participants are required to name the color ink of opposing color words (e.g., the word "blue" written in red ink with the correct response being "red"). Digit Span forward is a measure of simple attention. Participants repeat progressively longer series of numbers until the participant can no longer complete the task. Digit Span Backward is a measure of working memory. The participant repeats back a series of numbers in reverse order. The series length increase until the participant can no longer complete the task.	10 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session
Secondary	Montreal Cognitive Assessment (MOCA)	This is a tool used to screen for mild cognitive dysfunctions. It assesses different domains of cognition: attention, memory, language visuospatial skills, orientation, and calculations.	8 minutes; pre-test during the second research visit and post-test on 8th visit 14 days after last tDCS session