N/A
Completed N=8
The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood
Source: ClinicalTrials.gov NCT01860677 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits
Summary
Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits |
— | — |
| SECONDARY BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only |
0.2 | — |
| SECONDARY Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm |
1.88; -0.63 | — |
| SECONDARY Change in Visual Analogue Scale (VAS) in Active Stimulation Arm |
-2.90; 5.80; 1.10; -2.60; 2.30; 0.80 | — |
Eligibility Criteria
Inclusion Criteria
- 21 to 55 years old
- Otherwise physically healthy (normal physical exam, ECG, blood and urine chemistries)
- Female participants must use medically approved method of contraception. If barrier method is used, they must agree to using two methods simultaneously (e.g., diaphragm and condom).
- If on antidepressant or antianxiety medication, must be on a stable prescription regimen with no intentions to change drugs or dose during the next 11 weeks.
Exclusion Criteria
- Opiate maintenance (e.g., methadone or buprenorphine)
- Drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses.
- Meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or marihuana). Past abuse/dependence (greater than 3 years) is acceptable.
- Meets criteria for alcohol dependence. Past abuse/dependence (greater than 3 years) is acceptable. They may meet criteria for alcohol abuse.
- Physical health problems
- History of significant cardiac problems
- History of seizures
- Pregnancy
- Persons with a demand-type cardiac pacemaker
- Persons receiving vagus nerve simulation
- Persons receiving deep brain stimulation
- Participants cannot have any conditions that are contraindicated for MRI
Data sourced from ClinicalTrials.gov (NCT01860677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.