Study Summary
This trial is testing whether electrical stimulation of the brain can help reduce cognitive fatigue and improve cognitive function in patients with Parkinson's disease and mild cognitive impairment.
Eligible Conditions
- Mild Cognitive Impairment
- Parkinson's Disease
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 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
Day 14
McGill Quality of Life (QOL) Scale
Day 14
Neuropsychological battery (Stroop and Digit Span)
Day 14
Center for Epidemiological Studies Depression Scale (CES-D)
Multidimensional Fatigue Inventory (MFI)
Day 14
Montreal Cognitive Assessment (MOCA)
Day 14
Change in Error Rate on contextual cueing computer task
Change in Reaction Time (RT) on contextual cueing computer task
Trial Safety
Phase-Based Safety
Side Effects for
Transcranial Direct Current Stimulation
11%scalp burn
Trial Design
2 Treatment Groups
Experimental group
1 of 2
Sham group
1 of 2
Experimental Treatment
Non-Treatment Group
40 Total Participants · 2 Treatment Groups
Primary Treatment: transcranial direct current stimulation · Has Placebo Group · N/A
Experimental group
Device
Experimental Group · 1 Intervention: transcranial direct current stimulation · Intervention Types: DeviceSham group
Device
ShamComparator Group · 1 Intervention: Sham (for transcranial direct current stimulation) · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial direct current stimulation
2019
Completed Phase 3
~910
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Who is running the clinical trial?
Sanford HealthLead Sponsor
46 Previous Clinical Trials
61,900 Total Patients Enrolled
Jau-Shin Lou, MDPrincipal InvestigatorSanford Health
Eligibility Criteria
Age Any Age · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been diagnosed with Parkinson's disease and have at least two of the following symptoms: tremors, stiffness, slowness of movement, and difficulty with balance.
Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
References
- Brunoni, Andre Russowsky, Michael A. Nitsche, Nadia Bolognini, Marom Bikson, Tim Wagner, Lotfi Merabet, Dylan J. Edwards, et al.. 2012. “Clinical Research with Transcranial Direct Current Stimulation (tdcs): Challenges and Future Directions”. Brain Stimulation. Elsevier BV. doi:10.1016/j.brs.2011.03.002.
- Meinzer, Marcus, Sophia Jähnigen, David A. Copland, Robert Darkow, Ulrike Grittner, Keren Avirame, Amy D. Rodriguez, Robert Lindenberg, and Agnes Flöel. 2014. “Transcranial Direct Current Stimulation over Multiple Days Improves Learning and Maintenance of a Novel Vocabulary”. Cortex. Elsevier BV. doi:10.1016/j.cortex.2013.07.013.
- Lou, Jau-Shin, Greg Kearns, Barry Oken, Gary Sexton, and John Nutt. 2001. “Exacerbated Physical Fatigue and Mental Fatigue in Parkinson's Disease”. Movement Disorders. Wiley. doi:10.1002/mds.1042.
- Nitsche, M. A., and W. Paulus. 2000. “Excitability Changes Induced in the Human Motor Cortex by Weak Transcranial Direct Current Stimulation”. The Journal of Physiology. Wiley. doi:10.1111/j.1469-7793.2000.t01-1-00633.x.
- Boggio, Paulo S., Roberta Ferrucci, Sergio P. Rigonatti, Priscila Covre, Michael Nitsche, Alvaro Pascual-Leone, and Felipe Fregni. 2006. “Effects of Transcranial Direct Current Stimulation on Working Memory in Patients with Parkinson's Disease”. Journal of the Neurological Sciences. Elsevier BV. doi:10.1016/j.jns.2006.05.062.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2015. "Transcranial Direct Current Stimulation for Cognitive Improvement in Parkinson's Mild Cognitive Impairment (tDCS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03191916.
Frequently Asked Questions
Are there openings for enrolment in this research project?
"Affirmative. Evidence presented on clinicaltrials.gov verifies that this medical trial is presently enrolling participants, having been initially posted in October 2015 and most recently updated in November 2021. A total of 40 patients are required to be recruited from a single site." - Anonymous Online Contributor
Unverified Answer
How many individuals have elected to partake in the current clinical trial?
"Affirmative. Clinicaltrials.gov confirms that recruitment for this medical trial, which was initially advertised on October 19th 2015, is currently taking place. 40 participants need to be sourced from 1 site in particular." - Anonymous Online Contributor
Unverified Answer