Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy

NCT03198156 | Terminated Results DMC FDA Device

• 1 other identifier: 2016H0434
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in subjects with central hypersomnia without cataplexy.
2. 2.To determine the effects of tDCS on subjective measures of sleepiness and alertness in subjects with central hypersomnia without cataplexy.

Conditions

Hypersomnia

Keywords

Transcranial Direct Current Stimulation; Without Cataplexy

Outcome Measures

Primary Outcomes (2)

• Psychomotor Vigilance Test

  Objective measure of sleepiness.

  10 minutes

• Epworth Sleepiness Scale

  Subjective measure of sleepiness

  5 minutes

Secondary Outcomes (4)

• Stanford Sleepiness Scale

  5 minutes

• Functional Outcomes of Sleep Questionnaire

  5 minutes

• Visual Analogue Scale

  5 minutes

• CES-D Scale

  5 minutes

Study Arms (2)

Transcranial Direct Current Stimulation

EXPERIMENTAL

Active tDCS for 30 minutes daily for 4 sessions

Device: Transcranial Direct Current Stimulation

Sham stimulation

SHAM COMPARATOR

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.

Device: Sham stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Also known as: tDCS

Transcranial Direct Current Stimulation

Sham stimulation DEVICE

Sham stimulation

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 70 years
• Epworth Sleepiness scale score \>10
• Stable medication dosage over previous 4 weeks
• Able to understand English and read and write at the 8th grade level and give a written informed consent document.
• Stable sleep/wake schedule (that is, no rotating shift work)
• Clinical diagnosis of any of the following:
• Idiopathic Hypersomnia
• Narcolepsy without Cataplexy
• Hypersomnia in OSA patients adequately treated with PAP therapy or dental device
• Posttraumatic hypersomnia
• Hypersomnia, unspecified
• Subjects with idiopathic hypersomnia with an MSLT mean sleep latency of \> 8 minutes will be included provided they have hypersomnia symptoms and habitually long sleep times (average of \>10 hours per day) documented by actigraphy for at least 7 days.18

You may not qualify if:

• Self-reported habitual sleep period of \< 7 hours/night
• History of automobile accident due to falling asleep while driving
• Currently taking stimulant medications such as Modafinil, Armodafinil, Methylphenidate, or Dextroamphetamnie.
• Inability to understand or read English
• Clear history of cataplexy
• Moderate or severe sleep apnea defined as an apnea-hypopnea index (AHI) of \> 15/hour based on a previous sleep study and non-compliant with treatment.
• Self-reported Substance abuse (current)
• Excessive alcohol consumption defined as:
• More than 3 glasses of wine a day
• More than 3 beers a day
• More than 60 mL of hard liquor a day
• Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).
• Pregnancy, lactation
• Recent hospitalization for major surgery/major illness (within past 1 month)
• Non-removable metal or tattoos around head

Sponsors & Collaborators

• Ohio State University: lead
• United States Air Force: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

No data was analyzed. Study was terminated due to the funding was stopped.

Results Point of Contact

• Title: Dr. Ulysses Magalang
• Organization: The Ohio State University Wexner Medical Center

Ulysses.Magalang@osumc.edu

614-292- 4307

Study Officials

• Ulysses Magalang, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Neuroscience; Director, Sleep Medicine Program

Model Details: This is a 5 week randomized, sham-controlled, parallel group study involving subjects with any of the following diagnoses: Idiopathic Hypersomnia, Narcolepsy without Cataplexy, Hypersomnia in OSA patients adequately treated with PAP therapy or dental device, Posttraumatic hypersomnia, Hypersomnia, unspecified. Subjects with idiopathic hypersomnia with an MSLT mean sleep latency of \>8 minutes will undergo actigraphy and those with an average sleep time of \>10 hours per day will continue with the study while those with \<10 hours sleep time will be excluded. OSA subjects with complaints of hypersomnia with an ESS score \<10 will be excluded. Female subjects of child bearing age and not menopausal will have a pregnancy test performed. Subjects will receive either active tDCS or sham stimulation for 30 minutes daily for 4 sessions. Subjects will be blinded as to whether they are receiving sham or active tDCS treatments.

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 26, 2017
• Study Start: September 1, 2017
• Primary Completion: June 20, 2020
• Study Completion: June 20, 2020
• Last Updated: October 25, 2021
• Results First Posted: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)