Low Voltage Electrical Stimulation for Depression in Parkinson's Patients

Part of paid clinical trials in Mobile, Alabama.

Sponsor
University of South Alabama
Study ID
NCT06467695
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • BIOPAC Stimsola — DEVICE
    Transcranial Electrical Stimulator
  • BIOPAC Stimsola Sham (zero amps) — DEVICE
    Transcranial Electrical Stimulator set to 0 amps

Study Details

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?

Key Dates

Start date
Aug 1, 2024
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Electrical Stimulation (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.
  • Sham Comparator: Sham Stimulation
    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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South AlabamaMobileAlabama36688-

Find similar trials in Mobile, AL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of South Alabama· Mobile, AL

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