Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD
ConditionParkinsons Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSanford Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with dementia (MOCA < 21)
PD treatment using deep brain stimulation (DBS)
Diagnosis of psychosis
Diagnosis of multiple sclerosis
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial direct current stimulation (tDCS)
Device2 mA will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.
Sham (No Treatment)
DeviceFor 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
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Sham GroupSham comparator 1 intervention
Trial outcomes
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.
Time frame
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 sessionSecondary outcomes
1
Montreal Cognitive Assessment (MOCA)
This is a tool used to screen for mild cognitive dysfunctions. It assesses different domains of cognition: attention, memory, language visuospatial skills, orientation, and calculations. It determines the cut-off for dementia.
Time frame
8 minutes; pre-test during the second research visit.2
The Multidimensional Fatigue Inventory (MFI)
This is a 20-item self-report instrument that measures five dimensions of fatigue independently: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.
Time frame
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 session3
Center for Epidemiological Studies Depression Scale (CES-D).
This is a tool used to screen for symptoms of depression.
Time frame
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 session4
McGill Quality of Life (QOL) Scale
This is a single item tool to assess quality of life on all parts of life (physical, emotional, social, spiritual, and financial.
Time frame
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 sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov