Parkinson DiseaseLVESDIPPNCT06467695
Low Voltage Electrical Stimulation for Depression in Parkinson's Patients
A study testing BIOPAC Stimsola in people with Parkinson Disease and Depressive Symptoms, run by University of South Alabama at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Parkinson Disease, Depressive Symptoms
- What is being tested?
- BIOPAC Stimsola
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Alabama
Mobile, Alabama, 36688
About this study
Official title: The Effect of MRI-Guided Transcranial Direct Current Stimulation on Cognitive and Affective Symptoms in Persons With Parkinson's Disease and Controls
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?
Read the detailed 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.
- Conditions
- Parkinson Disease, Depressive Symptoms
- Being tested
- BIOPAC Stimsola, BIOPAC Stimsola Sham (zero amps)
- Keywords
- Direct Transcranial Current Stimulation
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOPAC StimsolaDevice
Transcranial Electrical Stimulator
BIOPAC Stimsola Sham (zero amps)Device
Transcranial Electrical Stimulator set to 0 amps
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation (experimental) | Experimental | Transcranial Direct Current Stimulation will be administered in a high definition anodal montage at 2 milliamps with anode over T3 (adjusted for each participant) and cathode in an equidistance ring around it with 4 return electrodes. There will be 13 minutes of active stimulation followed by a twenty minute delay, followed by 13 minutes of stimulation. Participants in the pilot study will be administered 2 mA of current at a steady state with a 30 second ramp-up and ramp-down period at the beginning and end of each 13 minute stimulation interval. Receives: Device: BIOPAC Stimsola |
| Sham Stimulation | Sham comparator | For the sham TDCS condition, 10 participants will receive receive sham tDCS consisting of 30 seconds of ramp-up and then the amperage will be reduced to 0 for the remainder of the session. Receives: Device: BIOPAC Stimsola Sham (zero amps) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Alpha band power pre-post change score
Alpha band power from pre-post eeg records will be assessed for power changes at frontal sites.
Measured: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
RBANS Working Memory
Digit Span and Story Memory subtests will be used to determine changes in working memory.
Measured: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Secondary outcomes (1)
PDQ-39
This a common measure to assess patient quality of life in Parkinson Disease patients involved in research.
Measured: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Aug 2024
- Primary completion1 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants (n = 40) will be either in the Parkinson's Group (n = 20) or the No Parkinson's Control (N = 20). All patients will be randomly assigned to receive either tDCS or SHAM tDCS.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Shelley-Tremblay, PhD, Principal investigator, 2514606883
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467695
- Sponsor's protocol ID
- 2128181
- Acronym
- LVESDIPP
- Status last verified
- Apr 2026
- First submitted
- 1 May 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30921609Brak 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.
PubMed 35903808Broeder 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.
PubMed 36952012Broeder 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.
PubMed 26297812de 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.
PubMed 35082749
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of MRI-Guided Transcranial Direct Current Stimulation on Cognitive and Affective Symptoms in Persons With Parkinson's Disease and Controls
- ClinicalTrials.gov ID
- NCT06467695
- Acronym / sponsor ID
- LVESDIPP / 2128181
- Conditions
- Parkinson Disease, Depressive Symptoms
- Keywords
- Direct Transcranial Current Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants (n = 40) will be either in the Parkinson's Group (n = 20) or the No Parkinson's Control (N = 20). All patients will be randomly assigned to receive either tDCS or SHAM tDCS.
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation (experimental) | Experimental | Device: BIOPAC StimsolaTranscranial Direct Current Stimulation will be administered in a high definition anodal montage at 2 milliamps with anode over T3 (adjusted for each participant) and cathode in an equidistance ring around it with 4 return electrodes. There will be 13 minutes of active stimulation followed by a twenty minute delay, followed by 13 minutes of stimulation. Participants in the pilot study will be administered 2 mA of current at a steady state with a 30 second ramp-up and ramp-down period at the beginning and end of each 13 minute stimulation interval. |
| Sham Stimulation | Sham comparator | Device: BIOPAC Stimsola Sham (zero amps)For the sham TDCS condition, 10 participants will receive receive sham tDCS consisting of 30 seconds of ramp-up and then the amperage will be reduced to 0 for the remainder of the session. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOPAC StimsolaTranscranial Electrical Stimulator | Device | Electrical Stimulation (experimental) |
| BIOPAC Stimsola Sham (zero amps)Transcranial Electrical Stimulator set to 0 amps | Device | Sham Stimulation |
Primary outcome
Beck Depression Inventory (BDI) Pre-post change score
Time frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
The BDI, a self-report measure for assessing depression, has high internal consistency (Cronbach's alpha > .90) and good test-retest reliability.
Alpha band power pre-post change score
Time frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Alpha band power from pre-post eeg records will be assessed for power changes at frontal sites.
RBANS Working Memory
Time frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Digit Span and Story Memory subtests will be used to determine changes in working memory.
1 secondary outcome
PDQ-39
Time frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 30921609Del 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.
- Background: PubMed 35903808Brak 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.
- Background: PubMed 36952012Broeder 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.
- Background: PubMed 26297812Broeder 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.
- Background: PubMed 35082749de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Shelley-Tremblay, PhD principal investigator
2514606883
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOPAC Stimsola in people with Parkinson Disease and Depressive Symptoms, run by University of South Alabama at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John F Shelley-Tremblay, PhD (2514606883, jstremblay@southalabama.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (BDI) Pre-post change score (time frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06467695, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.