Low Voltage Electrical Stimulation for Depression in Parkinson's Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorUniversity of South Alabama
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
BIOPAC Stimsola
DeviceTranscranial Electrical Stimulator
BIOPAC Stimsola Sham (zero amps)
DeviceTranscranial Electrical Stimulator set to 0 amps
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Electrical Stimulation (experimental)Experimental treatment 1 intervention
Group B: Sham StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.2
Alpha band power pre-post change score
Alpha band power from pre-post eeg records will be assessed for power changes at frontal sites.
Time frame
One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.3
RBANS Working Memory
Digit Span and Story Memory subtests will be used to determine changes in working memory.
Time frame
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.
Time frame
One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov