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Behavioural Intervention

Electrical Brain Stimulation for Parkinson's Disease (tDCS Trial)

N/A

Recruiting

Led By Jau-Shin Lou, MD

Research Sponsored by Sanford Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability)

Must not have

PD treatment using deep brain stimulation (DBS)

Diagnosis of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tdcs, a follow up test on the 7th research visit, 7 days after last tdcs session and 8th visit 14 days after last tdcs session

Summary

This trial is testing whether electrical stimulation of the brain can help reduce cognitive fatigue and improve cognitive function in patients with Parkinson's disease and mild cognitive impairment.

Who is the study for?

This trial is for Parkinson's patients with mild cognitive impairment (MOCA scores between 21 and 26) who exhibit at least two of the main symptoms: tremor, rigidity, bradykinesia, or postural instability. Participants must be able to give consent and speak English fluently. Those with severe lung, heart, kidney diseases, dementia, deep brain stimulation treatment for PD, psychosis, multiple sclerosis, stroke history or epilepsy cannot join.

What is being tested?

The study tests if a non-invasive brain stimulation technique called anodal transcranial direct current stimulation (atDCS), applied to the left dorsolateral prefrontal cortex can improve cognition and reduce fatigue in Parkinson's patients compared to a sham (fake) procedure.

What are the potential side effects?

Possible side effects from tDCS may include slight itching or tingling on the scalp during application; headache; fatigue; nausea; and insomnia. These are typically mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Parkinson's disease with symptoms like tremor or stiffness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving or have received DBS for Parkinson's disease.

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I have been diagnosed with epilepsy.

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I have been diagnosed with congestive heart failure.

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I have been diagnosed with chronic obstructive pulmonary disease.

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I have been diagnosed with renal failure.

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I am not fluent in English.

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I have been diagnosed with a stroke.

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I have been diagnosed with psychosis.

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I have been diagnosed with multiple sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tdcs, a follow up test on the 7th research visit, 7 days after last tdcs session and 8th visit 14 days after last tdcs session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tdcs, a follow up test on the 7th research visit, 7 days after last tdcs session and 8th visit 14 days after last tdcs session

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tdcs, a follow up test on the 7th research visit, 7 days after last tdcs session and 8th visit 14 days after last tdcs session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Reaction Time (RT) on contextual cueing computer task

Secondary study objectives

Center for Epidemiological Studies Depression Scale (CES-D)

Change in Error Rate on contextual cueing computer task

McGill Quality of Life (QOL) Scale

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental groupExperimental Treatment1 Intervention

The experimental group will receive 2 milliamps of anodal transcranial direct current stimulation for 20 minutes daily for 5 days.

Group II: Sham groupPlacebo Group1 Intervention

The sham group will be connected to the anodal transcranial direct current stimulation device daily for 5 days. During the 20 minute sessions, the participant will only receive stimulation for a 30-second ramp up period, at which point the stimulation will be discontinued for the remainder of the time.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

transcranial direct current stimulation

2013

Completed Phase 3

~1430

0 / 10Eligibility criteria met