Weight LossTDCSNCT05609604
Role of Transcranial Direct Current Stimulation in Appetite and Weight Control
A study testing tDCS in people with Weight Loss and Appetite Loss, run by University at Buffalo at 1 site in United States.
Trial summary
To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Weight Loss, Appetite Loss
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 to 80 years of age
- Body mass index > 30 kg/m2
Who cannot join
- 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:
- phentermine, naltrexone, bupropion, topiratmate, lorcaserin, phendimetrazine, methamphetamine, benzphetamine, diethylpropion
Show all 12Show fewer
- Any contraindication to receive transcranial direct current stimulation (tDCS):
- Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
- Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).
- Prior neurosurgical procedure or radiation.
- Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, Transcutaneous Electrical Nerve Stimulation unit, ventriculo-peritoneal shunt or any metallic implant on the head.
Trial locations and contacts
1 site in 1 country.
United States1 site
ECMC Ambulatory Center, 3rd Floor
Buffalo, New York, 14215
About this study
Official title: Role of Trans-cranial Direct Current Stimulation in Appetite and Weight Control: A Prospective Randomized Study
To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.
Read the detailed description
- To compare weight loss over one month in active tDCS group with sham tDCS group. The investigator will measure weight of every participants at the beginning of the study and one month after the last session of tDCS
- To compare change in insulin sensitivity over one month in active tDCS group with sham tDCS group. The investigator will measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance (HOMA-IR)
- To compare change in cognitive performance as a response to food over one month in active tDCS group with sham tDCS group. The investigator will evaluate performance in a computerized task that measures executive functions under the presence of food (working memory, inhibitory control and a combination of both). The investigator will assess changes in accuracy and speed in the task under active tDCS versus sham tDCS.
- To compare change in post-prandial glucose excursion and average meal counts per day. The investigator will use continuous glucose monitor to record the frequency and amplitude of glucose excursion.
- Conditions
- Weight Loss, Appetite Loss
- Being tested
- tDCS, Shame- No current
- Keywords
- TDCS, Obesity, Appetite, Weight loss
- Medical subject headings
- Weight Loss, Anorexia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Electric current will be delivered to the pre-frontal cortex for 30 minutes.
Shame- No currentDevice
Also called No current control arm
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Active comparator | This group will receive 30 minutes of active stimulation from tDCS Receives: Device: tDCS |
| sham tDCS | Placebo comparator | This group will receive 30 minutes of sham (placebo) stimulation from tDCS Receives: Device: Shame- No current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
change in body weight in Kg measured from baseline at 5 weeks
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study startJan 2017
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Why it stopped: No trained/ qualified staff available to perform study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Paresh Dandona, University at Buffalo
- Investigators
- Paresh Dandona, MD, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609604
- Sponsor's protocol ID
- TDCS Weight Loss
- Acronym
- TDCS
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2017
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Trans-cranial Direct Current Stimulation in Appetite and Weight Control: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05609604
- Acronym / sponsor ID
- TDCS / TDCS Weight Loss
- Conditions
- Weight Loss, Appetite Loss
- Keywords
- TDCS, Obesity, Appetite, Weight loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No trained/ qualified staff available to perform study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- Jan 2017 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.
Detailed description
- To compare weight loss over one month in active tDCS group with sham tDCS group. The investigator will measure weight of every participants at the beginning of the study and one month after the last session of tDCS
- To compare change in insulin sensitivity over one month in active tDCS group with sham tDCS group. The investigator will measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance (HOMA-IR)
- To compare change in cognitive performance as a response to food over one month in active tDCS group with sham tDCS group. The investigator will evaluate performance in a computerized task that measures executive functions under the presence of food (working memory, inhibitory control and a combination of both). The investigator will assess changes in accuracy and speed in the task under active tDCS versus sham tDCS.
- To compare change in post-prandial glucose excursion and average meal counts per day. The investigator will use continuous glucose monitor to record the frequency and amplitude of glucose excursion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Device: tDCSThis group will receive 30 minutes of active stimulation from tDCS |
| sham tDCS | Placebo comparator | Device: Shame- No currentThis group will receive 30 minutes of sham (placebo) stimulation from tDCS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women 18 to 80 years of age
- Body mass index > 30 kg/m2
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSElectric current will be delivered to the pre-frontal cortex for 30 minutes. | Device | active tDCS |
| Shame- No currentAlso: No current control arm | Device | sham tDCS |
Primary outcome
Change in Body Weight
Time frame: 5 weeks
change in body weight in Kg measured from baseline at 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paresh Dandona, MD principal investigator
SUNY Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Weight Loss and Appetite Loss, run by University at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.