Not provided
Not provided
Not provided
Not provided
No trained/ qualified staff available to perform study.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
Not provided
Not provided
Not provided
To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS | Active Comparator | This group will receive 30 minutes of active stimulation from tDCS |
|
| sham tDCS | Placebo Comparator | This group will receive 30 minutes of sham (placebo) stimulation from tDCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Electric current will be delivered to the pre-frontal cortex for 30 minutes. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | change in body weight in Kg measured from baseline at 5 weeks | 5 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Current participation in any other concurrent clinical trials or previous participation within 30 days before the screening visit
Pregnancy or premenopausal women who are trying to be pregnant
Patients who are incompetent to give consent
Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
Have taken any of the following medications within the past 3 months:
Any contraindication to receive transcranial direct current stimulation (tDCS):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paresh Dandona, MD | SUNY Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECMC Ambulatory Center, 3rd Floor | Buffalo | New York | 14215 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | This group will receive 30 minutes of active stimulation from tDCS tDCS: Electric current will be delivered to the pre-frontal cortex for 30 minutes. |
| FG001 | Sham tDCS | This group will receive 30 minutes of sham (placebo) stimulation from tDCS Shame- No current |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | This group will receive 30 minutes of active stimulation from tDCS tDCS: Electric current will be delivered to the pre-frontal cortex for 30 minutes. |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight | change in body weight in Kg measured from baseline at 5 weeks | no patient completed the study due to study termination due to departure of trained staff. | Posted | 5 weeks |
|
5 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | This group will receive 30 minutes of active stimulation from tDCS tDCS: Electric current will be delivered to the pre-frontal cortex for 30 minutes. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paresh Dandona | UBuffalo | 17168818924 | ghanim@buffalo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2017 | Jan 3, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D000855 | Anorexia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Shame- No current |
| Device |
|
|
This group will receive 30 minutes of sham (placebo) stimulation from tDCS
Shame- No current
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | Kg/m2 |
|
| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Sham tDCS | This group will receive 30 minutes of sham (placebo) stimulation from tDCS Shame- No current | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
Not provided
| D012817 | Signs and Symptoms, Digestive |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |