Trial Outcomes & Findings for Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease (NCT NCT04046055)

Results Overview

Walk as fast and as safe as possible over 30 meter

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

10 minutes

Results posted on

2022-11-10

Participant Flow

All subjects in this study completed all of the study arms (repeated-measure design).

Participant milestones

Participant milestones
Measure	Sham/2mA/ Unilateral 2 mA/ Bilateral 2 mA/ Unilateral 4 mA /Bilateral 4 mA) Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias. A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA or 4 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA/4mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Overall Study STARTED	7
Overall Study Sham	7
Overall Study Unilateral, 2 mA	7
Overall Study Bilateral, 2 mA	7
Overall Study Unilateral, 4 mA	7
Overall Study Bilateral, 4 mA	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham, Unilateral 2 mA, Bilateral 2 mA, Unilateral 4 mA, and Bilateral 4 mA) n=7 Participants Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias. A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA/4mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes. Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA/4mA for the remainder of the stimulation time.
Age, Continuous	72.4 years STANDARD_DEVIATION 6.4 • n=7 Participants
Sex: Female, Male Female	2 Participants n=7 Participants
Sex: Female, Male Male	5 Participants n=7 Participants
Region of Enrollment United States	7 Participants n=7 Participants
UPDRS-III	32.6 Scores on scale STANDARD_DEVIATION 14.2 • n=7 Participants

PRIMARY outcome

Timeframe: 10 minutes

Walk as fast and as safe as possible over 30 meter

Outcome measures

Outcome measures
Measure	Sham 4 mA n=7 Participants Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.	Unilateral 2 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 2 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Unilateral 4 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 4 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Speed Walked During 30 Meter Walk Test	5.63 meters per second (m/s) Standard Deviation 0.84	5.65 meters per second (m/s) Standard Deviation 1.04	5.77 meters per second (m/s) Standard Deviation 1.07	5.86 meters per second (m/s) Standard Deviation 1.06	5.77 meters per second (m/s) Standard Deviation 1.24

PRIMARY outcome

Timeframe: 10 minutes

From a seated position, stand up, walk 5 meters, turn around, walk back, and sit back down in the chair.

Outcome measures

Outcome measures
Measure	Sham 4 mA n=7 Participants Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.	Unilateral 2 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 2 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Unilateral 4 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 4 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Time to Complete the Timed Up and Go Test	11.9 seconds (s) Standard Deviation 2.7	12.43 seconds (s) Standard Deviation 2.32	12.80 seconds (s) Standard Deviation 2.42	12.42 seconds (s) Standard Deviation 2.72	12.70 seconds (s) Standard Deviation 3.28

PRIMARY outcome

Timeframe: 1 minute

Stand as still as possible on a firm surface for 1 minute with the eyes open. Calculate the area of an ellipse that contains 95% of the 2D trace of the center of pressure movement.

Outcome measures

Outcome measures
Measure	Sham 4 mA n=7 Participants Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.	Unilateral 2 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 2 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Unilateral 4 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 4 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Movement of the Center of Pressure (2D; Forward-backward, Left-right) While Standing on a Firm Surface (Force Platform) for 1 Minute	3.22 centimeters squared (cm^2) Standard Deviation 2.56	2.47 centimeters squared (cm^2) Standard Deviation 2.34	1.72 centimeters squared (cm^2) Standard Deviation 0.50	1.60 centimeters squared (cm^2) Standard Deviation 0.74	1.57 centimeters squared (cm^2) Standard Deviation 0.39

PRIMARY outcome

Timeframe: 1 minute

Stand as still as possible on a foam surface for 1 minute with the eyes open. Calculate the area of an ellipse that contains 95% of the 2D trace of the center of pressure movement.

Outcome measures

Outcome measures
Measure	Sham 4 mA n=7 Participants Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.	Unilateral 2 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 2 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Unilateral 4 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 4 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Movement of the Center of Pressure (2D; Forward-backward, Left-right) While Standing on a Foam Surface (6 cm Foam Pad Placed on Top of Force Platform) for 1 Minute	8.34 centimeters squared (cm^2) Standard Deviation 7.57	7.53 centimeters squared (cm^2) Standard Deviation 4.35	9.36 centimeters squared (cm^2) Standard Deviation 6.90	8.30 centimeters squared (cm^2) Standard Deviation 6.40	7.60 centimeters squared (cm^2) Standard Deviation 3.63

SECONDARY outcome

Timeframe: 1 minute

Stand as still as possible on a firm surface for 1 minute with the eyes open.

Outcome measures

Outcome measures
Measure	Sham 4 mA n=7 Participants Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.	Unilateral 2 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 2 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Unilateral 4 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 4 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Movement of the Center of Pressure (1D; Forward-backward) While Standing on a Firm Surface (Force Platform) for 1 Minute	2.38 centimeters (cm) Standard Deviation 0.70	2.90 centimeters (cm) Standard Deviation 0.91	2.25 centimeters (cm) Standard Deviation 0.62	2.25 centimeters (cm) Standard Deviation 0.69	2.86 centimeters (cm) Standard Deviation 1.02

SECONDARY outcome

Timeframe: 1 minute

Stand as still as possible on a firm surface for 1 minute with the eyes open.

Outcome measures

Outcome measures
Measure	Sham 4 mA n=7 Participants Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.	Unilateral 2 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 2 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Unilateral 4 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 4 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Movement of the Center of Pressure (1D; Left-Right) While Standing on a Firm Surface (Force Platform) for 1 Minute	2.1 centimeters (cm) Standard Deviation 1.8	1.4 centimeters (cm) Standard Deviation 0.6	1.3 centimeters (cm) Standard Deviation 0.3	1.1 centimeters (cm) Standard Deviation 0.4	1.1 centimeters (cm) Standard Deviation 0.4

SECONDARY outcome

Timeframe: 1 minute

Stand as still as possible on a foam surface for 1 minute with the eyes open.

Outcome measures

Outcome measures
Measure	Sham 4 mA n=7 Participants Sham transcranial direct current stimulation: Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.	Unilateral 2 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 2 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 2 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Unilateral 4 mA n=7 Participants A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.	Bilateral 4 mA n=7 Participants Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Transcranial direct current stimulation at 4 mA: Uses weak electrical current to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Movement of the Center of Pressure (1D; Forward-backward) While Standing on a Foam Surface (6 cm Foam Pad Placed on Top of Force Platform) for 1 Minute	4.4 centimeters (cm) Standard Deviation 2.8	4.0 centimeters (cm) Standard Deviation 1.1	4.5 centimeters (cm) Standard Deviation 1.8	4.11 centimeters (cm) Standard Deviation 1.41	4.08 centimeters (cm) Standard Deviation 1.19

SECONDARY outcome

Timeframe: 1 minute

Stand as still as possible on a foam surface for 1 minute with the eyes open.