transcranial direct current stimulation for Mild Cognitive Impairment

Sanford Brain & Spine Center, Fargo, ND
Mild Cognitive Impairment+1 More Conditionstranscranial direct current stimulation - Device
Eligibility
Any Age
All Sexes

Study 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.

Eligible Conditions
  • Mild Cognitive Impairment
  • Parkinson's Disease

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 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

Day 14
McGill Quality of Life (QOL) Scale
Day 14
Neuropsychological battery (Stroop and Digit Span)
Day 14
Center for Epidemiological Studies Depression Scale (CES-D)
Multidimensional Fatigue Inventory (MFI)
Day 14
Montreal Cognitive Assessment (MOCA)
Day 14
Change in Error Rate on contextual cueing computer task
Change in Reaction Time (RT) on contextual cueing computer task

Trial Safety

Side Effects for

Transcranial Direct Current Stimulation
11%scalp burn
This histogram enumerates side effects from a completed 2011 Phase 1 & 2 trial (NCT00481988) in the Transcranial Direct Current Stimulation ARM group. Side effects include: scalp burn with 11%.

Trial Design

2 Treatment Groups

Experimental group
1 of 2
Sham group
1 of 2

Experimental Treatment

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: transcranial direct current stimulation · Has Placebo Group · N/A

Experimental group
Device
Experimental Group · 1 Intervention: transcranial direct current stimulation · Intervention Types: Device
Sham group
Device
ShamComparator Group · 1 Intervention: Sham (for transcranial direct current stimulation) · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial direct current stimulation
2019
Completed Phase 3
~910

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

Sanford HealthLead Sponsor
46 Previous Clinical Trials
61,900 Total Patients Enrolled
Jau-Shin Lou, MDPrincipal InvestigatorSanford Health

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Parkinson's disease and have at least two of the following symptoms: tremors, stiffness, slowness of movement, and difficulty with balance.

Who else is applying?

What state do they live in?
North Carolina100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

Are there openings for enrolment in this research project?

"Affirmative. Evidence presented on clinicaltrials.gov verifies that this medical trial is presently enrolling participants, having been initially posted in October 2015 and most recently updated in November 2021. A total of 40 patients are required to be recruited from a single site." - Anonymous Online Contributor

Unverified Answer

How many individuals have elected to partake in the current clinical trial?

"Affirmative. Clinicaltrials.gov confirms that recruitment for this medical trial, which was initially advertised on October 19th 2015, is currently taking place. 40 participants need to be sourced from 1 site in particular." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.