Trial Outcomes & Findings for Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding (NCT NCT01632280)

NCT ID: NCT01632280

Last Updated: 2019-01-07

Results Overview

Participants will be weighed at the indicated time points. Weight loss at 12 months will be the primary outcome of the study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up
• Results posted on: 2019-01-07

Participant Flow

Participants were recruited between June 2012 and July 2014 from the Weight Loss Surgery Center at Beth Israel Deaconess Medical Center.

2 participants withdrew from the study after enrollment but prior to assignment to a treatment arm.

Participant milestones

Measure	Active tDCS In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.	Sham tDCS In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
Overall Study STARTED	6	6
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Active tDCS In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.	Sham tDCS In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding

Baseline characteristics by cohort

Measure	Active tDCS n=6 Participants In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.	Sham tDCS n=6 Participants In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.	Total n=12 Participants Total of all reporting groups
Age, Continuous	42.3 years STANDARD_DEVIATION 8.0 • n=5 Participants	44.3 years STANDARD_DEVIATION 7.1 • n=7 Participants	43.3 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up

Population: 1 Participant withdrew prior to obtaining outcome data at the 10th day of tDCS, 1 participant was lost to follow-up prior to the 3-month follow-up visit, and 1 participants were lost to follow-up prior to obtaining outcome data at the 6-month follow-up visit.

Participants will be weighed at the indicated time points. Weight loss at 12 months will be the primary outcome of the study.

Outcome measures

Measure	Active tDCS n=6 Participants In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.	Sham tDCS n=6 Participants In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
Weight Change 1 month follow-up	273.4 pounds (lbs) Standard Deviation 57.0	220.3 pounds (lbs) Standard Deviation 34.1
Weight Change Baseline	285.0 pounds (lbs) Standard Deviation 63.8	245.3 pounds (lbs) Standard Deviation 41.0
Weight Change 2 weeks post gastric band (LAGB) surgery	273.4 pounds (lbs) Standard Deviation 62.7	228.4 pounds (lbs) Standard Deviation 34.8
Weight Change 10th day of tDCS	280.4 pounds (lbs) Standard Deviation 62.1	225.8 pounds (lbs) Standard Deviation 34.0
Weight Change 3 month follow-up	268 pounds (lbs) Standard Deviation 52.1	210.6 pounds (lbs) Standard Deviation 34.9
Weight Change 6 month follow-up	278.05 pounds (lbs) Standard Deviation 52.5	206.5 pounds (lbs) Standard Deviation 31.0
Weight Change 12 month follow-up	289.8 pounds (lbs) Standard Deviation 58.8	204.2 pounds (lbs) Standard Deviation 30.5

SECONDARY outcome

Timeframe: Baseline and 12 months follow up

Population: 1 participant withdrew prior to the 12 month follow-up and 2 participants were lost to follow-up prior to the 12 month follow-up.

Eating Disinhibition is an eating behavior trait that reflects a tendency towards overeating and eating opportunistically in an obesogenic environment. Examples include eating in response to negative affect, overeating when others are eating, not being able to resist temptations to eat, and overeating in response to the palatability of food (Bryant, King and Blundell. Obes Rev. 2008;9:409-19). Eating disinhibition was measured using the Three Factor Eating Questionnaire (TFEQ), which contains 16 questions for this factor. Responses are scored 0 or 1 and summed, thus eating disinhibition score ranges from 0 to 16. Higher scores denote higher levels of eating disinhibition.

Outcome measures

Measure	Active tDCS n=6 Participants In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.	Sham tDCS n=6 Participants In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
Eating Disinhibition as Measured by the Three Factor Eating Questionnaire (TFEQ) Baseline	7.0 units on a scale Standard Deviation 5.4	3.8 units on a scale Standard Deviation 2.1
Eating Disinhibition as Measured by the Three Factor Eating Questionnaire (TFEQ) 12 month follow-up	5.0 units on a scale Standard Deviation 1.2	3.6 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 12 month follow-up vs. Baseline

Population: 1 participant withdrew prior to the 12 month follow-up and 2 participants were lost to follow-up prior to the 12 month follow-up.

Inhibitory control over food was measured with a Stop Signal Task that was modified with the presence of distractors of two types: images of food and neutral images (control). The Stop Signal Task is a computerized task that evaluates an individual's ability to interrupt a motor response after its initiation (Logan 1994). Subjects were asked to press a response key matching the direction of an arrow, but refrain from pressing when an auditory cue ("stop signal") appeared (25% trials). The main outcome of the task is the Stop-Signal-Reaction-Time (SSRT), in milliseconds, which reflects how long it takes to inhibit a response when a stop signal appears. The SSRT is considered a laboratory measure of inhibitory control capacity. Shorter SSRT reflects more efficient inhibitory control. Here a reduction of SSRT from baseline to 12 months indicates improvement in inhibitory capacity. We provide SSRT changes for food and neutral images, reflecting specific and general effects, respectively.

Outcome measures

Measure	Active tDCS n=4 Participants In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.	Sham tDCS n=5 Participants In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
Change From Baseline in Inhibitory Control Over Food as Measured by the Stop Signal Reaction Task Change, stop signal reaction time, food images	-72.6 milliseconds (ms) Standard Deviation 68.3	-51.1 milliseconds (ms) Standard Deviation 49.8
Change From Baseline in Inhibitory Control Over Food as Measured by the Stop Signal Reaction Task Change, stop signal reaction time, neutral images	-62.3 milliseconds (ms) Standard Deviation 77.8	-46.4 milliseconds (ms) Standard Deviation 67.7

Adverse Events

Active tDCS

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active tDCS n=6 participants at risk In this arm, participants received 10 daily sessions of active Transcranial Direct Current Stimulation (2mA, 20 min per session) over the course of two weeks. The anode electrode was placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session participants performed a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.	Sham tDCS n=6 participants at risk In this arm, participants received 10 daily sessions of sham Transcranial Direct Current Sitmulation with the same duration and electrode montage as in the real tDCS arm (20 minutes, targeting the right inferior frontal gyrus). In this case, current was applied for 30 s only according to standard procedures, and participants performed a control task during which they observed and provided responses for the same food and non-food pictures as in the active group task, but without the requirement of inhibitory control for performance.
Investigations Headache	16.7% 1/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.	33.3% 2/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.
Investigations Neck pain	0.00% 0/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.	16.7% 1/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.
Investigations Sensations: burning, itching, or tingling	16.7% 1/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.	50.0% 3/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.
Investigations Skin redness	66.7% 4/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.	16.7% 1/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.
Investigations Sleepiness	100.0% 6/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.	100.0% 6/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.
Investigations Trouble concentrating	16.7% 1/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.	33.3% 2/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.
Investigations Acute mood change	16.7% 1/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.	16.7% 1/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.
Investigations Warmth at the site of the electrode	0.00% 0/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.	16.7% 1/6 • Two weeks Information about adverse events were collected using a side effects questionnaire administered at the beginning and end of transcranial direct current stimulation sessions.

Additional Information

Dr. Miguel Alonso-Alonso

Beth Israel Deaconess Medical Center

Phone: 617-667-0240

Email: malonso@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place