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The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample.
The goals of this study include:
Participants will be randomly assigned to one of two arms, Active, or Sham.
During the study, participants will perform the following:
Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Experimental | Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care. |
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| Control Arm | Sham Comparator | Subjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active RS-EFP | Device | A minimum of 10 and up to 15 active NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single booster sessions, one month and two months after their last training session. |
| Measure | Description | Time Frame |
|---|---|---|
| HDRS-21 | The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR) | The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome. |
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MDD subjects
Inclusion Criteria:
Exclusion Criteria (All Subjects):
Imaging Exclusions 1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
2. Contraindications to MRI (e.g., metal in the body, claustrophobia). 3. Hairstyles that prevent application of the EEG net (e.g., braids, dreadlocks, cornrows, recently dyed hair) Comorbidity Exclusions
Additional Substance and Drug Use Exclusions
Any current drug use as assessed by a positive result on urine drug test (covering cocaine, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates)
Use of any antibiotics in the 24 hours prior to an MRI scan procedure
Recent use (within 4 weeks) or any current medication that affects blood flow or blood pressure, or which is vasodilating/vasoconstricting (for participants undergoing neuroimaging) Medical Exclusions
1. Any unstable medical condition, as per the clinical judgement of the investigator.
2. A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
Treatment Exclusions
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| Name | Affiliation | Role |
|---|---|---|
| Diego Pizzagalli, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Sham RS-EFP | Device | a minimum of 10 and up to 15 sham NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single sham booster sessions, one month and two months after their last training session. |
|
| 9 weeks |
| HDRS-21 | The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes. | 3 months |
| Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR) | The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome. | 3 months |
| The clinical global impression (CGI-I) | The CGI-I Scale - of Clinical Global Impression (Guy et.al, 1976) - is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Rated within the range of 0 to 7, lower scores indicate improved outcomes while higher scores indicate worsen outcomes. | 9 weeks |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |