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Device

Transcranial Direct Current Stimulation for Parkinson's Disease

N/A
Recruiting
Led By Kelly Mills, M.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reporting disabling depressive or neuropsychiatric symptoms prior to study entry
Age 18 to 95 years old
Must not have
Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study
Diagnosis of Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder, or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month

Summary

This trial is studying whether a non-invasive brain stimulation technique can help improve non-motor symptoms in people with Parkinson's disease.

Who is the study for?
This trial is for adults aged 18-95 with Parkinson's disease who experience depressive or neuropsychiatric symptoms. They must understand the study, speak English, and not have brain diseases, skull defects, metal implants, certain psychiatric diagnoses, recent substance abuse or suicidal attempts.
What is being tested?
The study tests if transcranial direct current stimulation (tDCS) can help with depression and cognitive issues in Parkinson's patients. Participants will be randomly assigned to receive either real tDCS or a sham treatment over ten sessions lasting 30 minutes each.
What are the potential side effects?
Possible side effects of tDCS may include discomfort at the electrode site on the head, itching or tingling during stimulation, headache, fatigue and in rare cases mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe depression or mental health issues.
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I am between 18 and 95 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant nor planning to become pregnant during the study.
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I have been diagnosed with Bipolar, PTSD, Psychotic Disorder, or another non-unipolar depressive disorder in the last 6 months.
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I have no skull or scalp defects that would affect electrode placement.
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I am not taking medications like benzodiazepines, anticonvulsants, dextromethorphan, or pseudoephedrine.
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I do not have any known brain tumors or abscesses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
Secondary study objectives
Apathy Scores as measure by a self-report scale (the Apathy Scale)
Improvement of Parkinsonian Motor Symptoms
Performance on abbreviated cognitive battery
+3 more

Side effects data

From 2021 Phase 2 & 3 trial • 160 Patients • NCT02483468
2%
skin irritation
2%
Car accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA
Group II: Sham tDCSPlacebo Group1 Intervention
Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,686 Total Patients Enrolled
Kelly Mills, M.D.Principal InvestigatorJohns Hopkins University

Media Library

Transcranial Direct Current Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03074812 — N/A
Parkinson's Disease Research Study Groups: Active tDCS, Sham tDCS
Parkinson's Disease Clinical Trial 2023: Transcranial Direct Current Stimulation Highlights & Side Effects. Trial Name: NCT03074812 — N/A
Transcranial Direct Current Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03074812 — N/A
~2 spots leftby Mar 2025
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