Transcranial Direct Current Stimulation for Cognitive Improvement in Parkinson's Patients

NCT03191916 | Active Not Recruiting FDA Device

• 1 other identifier: SH tDCS Parkinsons
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral prefrontal cortex (LDLPFC) will induce long-lasting effects in improving cognitive function and reducing cognitive fatigue and fatigability in PD patients.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; tDCS; Cognitive function

Outcome Measures

Primary Outcomes (1)

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

  A visual search task will be given in which the participant looks for a T among L's. The contextual cuing task will consist of a practice block and forty test blocks. Eight of the trials in a block will consist of search configurations that repeat from block to block (repeat configurations); the other eight trials in a block will be randomly-generated configurations (new configurations). After the final trial, a recognition task will be presented to determine whether participants realized that repeat configurations were presented (not expected; cueing effects appear to result from implicit learning). Reaction time for each block will be recorded, with cognitive fatigue measured as deterioration of RT over the 40 blocks. This measure of change in RT will be compared across the 4 visits (pre-test, 6th visit, 7th visit, and 8th visit). Improved cognition fatigue based on tDCS treatment would predict reduced change in RT in the later visits compared to the pre-test.

  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

Secondary Outcomes (6)

• Change in Error Rate on contextual cueing computer task

  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

• Multidimensional Fatigue Inventory (MFI)

  5 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

• Center for Epidemiological Studies Depression Scale (CES-D)

  5 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

• McGill Quality of Life (QOL) Scale

  1 minute; 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

• Neuropsychological battery (Stroop and Digit Span)

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: transcranial direct current stimulation

Sham group

SHAM COMPARATOR

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.

Device: Sham (for transcranial direct current stimulation)

Interventions

transcranial direct current stimulation DEVICE

2milliamps will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.

Also known as: Magstim, HDCstim, HDCkit

Experimental group

Sham (for transcranial direct current stimulation) DEVICE

For 30 seconds the patient will experience a ramp up of the stimulation, after which point no stimulation will be transmitted for the remainder of the session. This will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.

Sham group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability)
• Meets criteria for MCI (21 ≤ MOCA scores ≤ 26)
• Must be able to consent

You may not qualify if:

• Patients with dementia (MOCA \< 21)
• PD treatment using deep brain stimulation (DBS)
• Diagnosis of psychosis
• Diagnosis of multiple sclerosis
• Diagnosis of stroke
• Diagnosis of epilepsy
• Diagnosis of chronic obstructive pulmonary disease
• Diagnosis of congestive heart failure
• Diagnosis of renal failure
• Participants not fluent in English

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (1)

Sanford Brain & Spine Center

Fargo, North Dakota, 58103, United States

Location

Related Publications (5)

• Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.

  PMID: 16843494 BACKGROUND

• Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.

  PMID: 22037126 BACKGROUND

• Lou JS, Kearns G, Oken B, Sexton G, Nutt J. Exacerbated physical fatigue and mental fatigue in Parkinson's disease. Mov Disord. 2001 Mar;16(2):190-6. doi: 10.1002/mds.1042.

  PMID: 11295769 BACKGROUND

• Meinzer M, Jahnigen S, Copland DA, Darkow R, Grittner U, Avirame K, Rodriguez AD, Lindenberg R, Floel A. Transcranial direct current stimulation over multiple days improves learning and maintenance of a novel vocabulary. Cortex. 2014 Jan;50:137-47. doi: 10.1016/j.cortex.2013.07.013. Epub 2013 Aug 6.

  PMID: 23988131 BACKGROUND

• Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

  PMID: 10990547 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jau-Shin Lou, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participant and their care provider will be blinded as to which intervention is being used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to an experimental group (receives stimulation) or a sham group (is set up with tDCS, but no stimulation is received)

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: June 19, 2017
• Study Start: October 19, 2015
• Primary Completion: August 7, 2025
• Study Completion: August 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)