Trial Outcomes & Findings for The Role of Cerebellar Hyperactivity in Parkinson's Disease (NCT NCT02349789)

Results Overview

Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants on medication.

Recruitment status

COMPLETED

Target enrollment

11 participants

Primary outcome timeframe

One session

Results posted on

2019-02-15

Participant Flow

Recruitment was conducted by the following means: Subjects were referred by local physicians and recruited from databases of previous studies of Co-investigators. Flyers were disseminated locally.

Participant milestones

Participant milestones
Measure	Parkinson's Subjects Participants with akinetic, rigid Parkinson's disease
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Parkinson's Subjects Participants with akinetic, rigid Parkinson's disease
Overall Study Withdrawal by Subject	2

Baseline Characteristics

The Role of Cerebellar Hyperactivity in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parkinson's Subjects n=11 Participants Participants with akinetic, rigid Parkinson's disease
Age, Continuous	64 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: One session

Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants on medication.

Outcome measures

Outcome measures
Measure	Parkinson's Subjects n=9 Participants Participants with akinetic, rigid Parkinson's disease
Change in Gait Speed- Sham_On	-0.0185 meters per second (m/s) Standard Error 0.0255

PRIMARY outcome

Timeframe: One session

Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants off medication.

Outcome measures

Outcome measures
Measure	Parkinson's Subjects n=9 Participants Participants with akinetic, rigid Parkinson's disease
Change in Gait Speed- Sham_Off	0.0078 meters per second (m/s) Standard Error 0.01076

PRIMARY outcome

Timeframe: One session

Change in overground walking speed (10 meter walk test) after Anodal transcranial direct current stimulation, participants on medication.

Outcome measures

Outcome measures
Measure	Parkinson's Subjects n=9 Participants Participants with akinetic, rigid Parkinson's disease
Change in Gait Speed- Anodal_On	-0.0477 meters per second (m/s) Standard Error 0.01947

PRIMARY outcome

Timeframe: One session

Change in overground walking speed (10 meter walk test) after Anodal transcranial direct current stimulation, participants off medication.

Outcome measures

Outcome measures
Measure	Parkinson's Subjects n=9 Participants Participants with akinetic, rigid Parkinson's disease
Change in Gait Speed- Anodal_Off	0.0346 meters per second (m/s) Standard Error 0.02359

PRIMARY outcome

Timeframe: One session

Change in overground walking speed (10 meter walk test) after Cathodal transcranial direct current stimulation, participants on medication.

Outcome measures

Outcome measures
Measure	Parkinson's Subjects n=9 Participants Participants with akinetic, rigid Parkinson's disease
Change in Gait Speed- Cathodal_On	-0.0059 meters per second (m/s) Standard Error 0.01908

PRIMARY outcome

Timeframe: One session

Change in overground walking speed (10 meter walk test) after cathodal transcranial direct current stimulation, participants off medication.

Outcome measures

Outcome measures
Measure	Parkinson's Subjects n=9 Participants Participants with akinetic, rigid Parkinson's disease
Change in Gait Speed- Cathodal_Off	-0.0502 meters per second (m/s) Standard Error 0.02521

Adverse Events

Parkinson's Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Gonzalez

Kennedy Krieger Institute

Phone: 4439080074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place