Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD

NCT06883266 | Recruiting FDA Device

• 1 other identifier: SH tDCS-Motor-PD
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left primary motor cortex (M1) will induce long-lasting effects in improving motor function and reducing motor fatigue and fatigability in PD patients.

Conditions

Parkinsons Disease (PD)

Keywords

Parkinsons Disease; tDCS; Motor Function; Motor Fatigue

Outcome Measures

Primary Outcomes (1)

• Finger and Toe-Tapping on KinesiaOne Device

  We will use the KinesiaOne measure the finger tapping and foot tapping for 15 seconds. It will repeat 3 times at 1 minute intervals. KinesiaOne is a light-weight device that can be attached to the Index finger or ankle. It measures the acceleration and deceleration of the finger or foot. The measurement is transmitted to the KinesiaOne tablet that allows further data processing.

  30 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 (5)

• Montreal Cognitive Assessment (MOCA)

  8 minutes; pre-test during the second research visit.

• The 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

• MDS-UPDRS Part II (patient self-report)

  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 2mA of anodal transcranial direct current stimulation (tDCS) for 20 minutes daily for 5 consecutive days.

Device: transcranial direct current stimulation (tDCS)

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 (No Treatment)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

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

Experimental Group

Sham (No Treatment) 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)
• 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 chronic obstructive pulmonary disease (COPD)
• Diagnosis of congestive heart failure (CHF)

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (1)

Sanford Brain and Spine Center

Fargo, North Dakota, 58103, United States

RECRUITING

Related Publications (1)

• 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

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

Central Study Contacts

Jessica Keller, B.S.

CONTACT

701-417-5781; jessica.keller@sanfordhealth.org

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: March 12, 2025
• First Posted: March 19, 2025
• Study Start: November 11, 2024
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)