Low Voltage Electrical Stimulation for Depression in Parkinson's Patients

Parkinson Disease Clinical Trial

— LVESDIPP  

Official title:

The Effect of MRI-Guided Transcranial Direct Current Stimulation on Cognitive and Affective Symptoms in Persons With Parkinson's Disease and Controls

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467695
• Other study ID #: 2128181
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: September 28, 2026

Study information

• Verified date: June 2024
• Source: University of South Alabama
• Contact: John F Shelley-Tremblay, PhD
• Phone: 2514606883
• Email: jstremblay[@]southalabama.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to determine the relative efficacy of fMRI model guided Transcranial Direct Current Stimulation (mgTDCS) in improving the depressive symptoms of patients with Parkinson's Disease (PD). The main questions it aims to answer are: 1) Can the use of mgTDCS significantly improve the self-reported level of depression and apathy in patients with PD from pre-intervention to post-intervention compared to a sham control? 2) Can the use of mgTDCS significantly normalize the cortical eeg alpha asymmetry so commonly seen in depressed patients compared to sham mgTDCS? 3) Can the use of mgTDCS significantly improve scores on neuropsychological tests of working memory?

Description:

This study seeks to expand the growing body of literature on the use of a particular type of low voltage electrical stimulation known as Transcranial Direct Current Stimulation (TDCS) to reduce the symptoms of Parkinson's Disease (PD). One common disorder that can result from, and/or be exacerbated by PD is Major Depressive Disorder. In particular, apathy has been noted as a common and detrimental component for those with PD. While many studies have been performed on PD patients using TDCS, the consensus in the literature is that results are widely variable. Participants will: - complete self-report measures and neuropsychological tests - undergo eeg recording pre and post intervention - participate in 15, 46 minute sessions (2 13 minute stimulation sessions with 20 minutes of rest between) of mgTDCS over the course of 4-5 weeks Researchers will compare active mgTDCS to Sham mgTDCS to see if active mgTDCS is more effective. A non Parkinson's group of depressed controls who are age-matched to the PD patients will serve to determine if treatment effects are specific to PD or generalize to depression more generally.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 28, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• 19 to 65 years in age.
• Parkinson's Group must have a physician dx of Parkinson's Disease
• Must meet exhibit elevated levels of depression on the Beck Depression Inventory (scores of 20 or above).
• Must be willing and able to travel of the Psychology Department for EEG and tDCS sessions.
• Participants who have undergone surgery for Deep Brain Stimulation implantation may be enrolled if advised to and monitored by their physician.
• Read and understand spoken English.

Exclusion Criteria:

• No history of or being treated for epilepsy or other seizure disorders.
• No history of penetrating head wounds or TBI greater than mild TBI.
• No history of atypical Parkinson's

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Parkinson Disease

Intervention

Device:
• BIOPAC Stimsola
Transcranial Electrical Stimulator
• BIOPAC Stimsola Sham (zero amps)
Transcranial Electrical Stimulator set to 0 amps

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of South Alabama

References & Publications (5)

Brak IV, Filimonova E, Zakhariya O, Khasanov R, Stepanyan I. Transcranial Current Stimulation as a Tool of Neuromodulation of Cognitive Functions in Parkinson's Disease. Front Neurosci. 2022 Jul 12;16:781488. doi: 10.3389/fnins.2022.781488. eCollection 2022. — View Citation

Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, Nieuwboer A. Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015 Oct;57:105-17. doi: 10.1016/j.neubiorev.2015.08.010. Epub 2015 Aug 20. — View Citation

Broeder S, Vandendoorent B, Hermans P, Nackaerts E, Verheyden G, Meesen R, de Xivry JO, Nieuwboer A. Transcranial direct current stimulation enhances motor learning in Parkinson's disease: a randomized controlled trial. J Neurol. 2023 Jul;270(7):3442-3450. doi: 10.1007/s00415-023-11669-3. Epub 2023 Mar 23. — View Citation

de Oliveira PCA, de Araujo TAB, Machado DGDS, Rodrigues AC, Bikson M, Andrade SM, Okano AH, Simplicio H, Pegado R, Morya E. Transcranial Direct Current Stimulation on Parkinson's Disease: Systematic Review and Meta-Analysis. Front Neurol. 2022 Jan 10;12:794784. doi: 10.3389/fneur.2021.794784. eCollection 2021. — View Citation

Del Felice A, Castiglia L, Formaggio E, Cattelan M, Scarpa B, Manganotti P, Tenconi E, Masiero S. Personalized transcranial alternating current stimulation (tACS) and physical therapy to treat motor and cognitive symptoms in Parkinson's disease: A randomized cross-over trial. Neuroimage Clin. 2019;22:101768. doi: 10.1016/j.nicl.2019.101768. Epub 2019 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory (BDI) Pre-post change score	The BDI, a self-report measure for assessing depression, has high internal consistency (Cronbach's alpha > .90) and good test-retest reliability.	One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Primary	Alpha band power pre-post change score	Alpha band power from pre-post eeg records will be assessed for power changes at frontal sites.	One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Primary	RBANS Working Memory	Digit Span and Story Memory subtests will be used to determine changes in working memory.	One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Secondary	PDQ-39	This a common measure to assess patient quality of life in Parkinson Disease patients involved in research.	One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.