Trial Outcomes & Findings for Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy (NCT NCT03198156)

NCT ID: NCT03198156

Last Updated: 2021-10-25

Results Overview

Objective measure of sleepiness.

Recruitment status

TERMINATED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

10 minutes

Results posted on

2021-10-25

Participant Flow

Of 39 enrolled subjects, 38 met inclusion criteria and were randomized to treatment

Participant milestones

Participant milestones
Measure	Transcranial Direct Current Stimulation Active tDCS for 30 minutes daily for 4 sessions Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.	Sham Stimulation Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds. Sham stimulation: Sham stimulation
Overall Study STARTED	19	19
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A total of 38 subjects age data were analyzed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Direct Current Stimulation n=19 Participants Active tDCS for 30 minutes daily for 4 sessions Transcranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.	Sham Stimulation n=19 Participants Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds. Sham stimulation: Sham stimulation	Total n=38 Participants Total of all reporting groups
Age, Continuous	38.63 years STANDARD_DEVIATION 11.34 • n=5 Participants • A total of 38 subjects age data were analyzed	38.84 years STANDARD_DEVIATION 14.27 • n=7 Participants • A total of 38 subjects age data were analyzed	38.73 years STANDARD_DEVIATION 25.61 • n=5 Participants • A total of 38 subjects age data were analyzed
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants
BMI	29.70 kg/m^2 STANDARD_DEVIATION 5.02 • n=5 Participants • A total of 38 subjects BMI were analyzed	29.84 kg/m^2 STANDARD_DEVIATION 6.67 • n=7 Participants • A total of 38 subjects BMI were analyzed	29.77 kg/m^2 STANDARD_DEVIATION 5.26 • n=5 Participants • A total of 38 subjects BMI were analyzed

PRIMARY outcome

Timeframe: 10 minutes

Population: Sleepiness measure data based on Psychomotor Vigilance Test results could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.

Objective measure of sleepiness.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 minutes

Population: Subjective Sleepiness data based on patient report on the Epwoth Sleepiness Scale questionnaire could not be analyzed and reported in data table as were unable to be collect data from enrolled patients. This study terminated early.

Subjective measure of sleepiness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 minutes

Population: Subjective Sleepiness data based on Stanford Sleepiness Scale instrument could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients. This study was early terminated.

Subjective measure of sleepiness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 minutes

Population: Impact of sleepiness on daytime function based on functional outcomes of sleep questionnaire could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.

Measure of the impact of sleepiness on daytime function

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 minutes

Population: Subjective Sleepiness data based on Visual Analogue Scale (VAS) could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.

Subjective Measure of Sleepiness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 minutes

Population: Data from Center for Epidemiologic Studies Depression (CES-D) Scale could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients

Center for Epidemiologic Studies Depression (CES-D) Scale

Outcome measures

Outcome data not reported

Adverse Events

Transcranial Direct Current Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Stimulation

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

Dr. Ulysses Magalang

The Ohio State University Wexner Medical Center

Phone: 614-292- 4307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place