Ignite Creation Date:
2024-05-06 @ 8:25 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02734108
Status:
COMPLETED
Last Update Posted:
2021-12-21
First Post:
2016-03-08
Brief Title:
Transcranial Direct Current Stimulation tDCS and Anorexia Nervosa
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Measuring the Effect of a Program of 20 Sessions of Transcranial Direct Current Stimulation With 2 Milli-ampere Targeting the Dorsolateral Prefrontal Cortex on the Symptoms of Anorexia Nervosa An Open Label Uncontrolled Pilots Study
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite the obvious thinness and extreme behaviors for weight loss The result is a massive weight loss and or pathological thinness The care of anorexia is difficult and few treatments have proved to be effective in adults
Transcranial direct current stimulation tDCS is a neuromodulation technique that uses an electrical current of low intensity It allows to modulate the corticospinal excitability two electrodes an anode excitatory and a cathode inhibitory are positioned on the skull according to the region which is desired to influence the operation
Although tDCS was shown to no noticeable side effects it is first necessary to assess the feasibility and safety of this technique in these physically frail patients A recent pilot study suggests the acceptability safety and efficacy of tDCS program in patients with anorexia nervosa
Given these preliminary data and the extreme seriousness and vulnerability of patients with resistant anorexia the investigators want to assess the risk benefit ratio for the use of this technique in patients suffering from resistant anorexia nervosa The current data are too preliminary to consider a randomized controlled trial the investigators hope initially replicate the data from this pilot study in a second sample with a more rigorous and comprehensive assessment methodology
Transcranial direct current stimulation tDCS is a neuromodulation technique that uses an electrical current of low intensity It allows to modulate the corticospinal excitability two electrodes an anode excitatory and a cathode inhibitory are positioned on the skull according to the region which is desired to influence the operation
Although tDCS was shown to no noticeable side effects it is first necessary to assess the feasibility and safety of this technique in these physically frail patients A recent pilot study suggests the acceptability safety and efficacy of tDCS program in patients with anorexia nervosa
Given these preliminary data and the extreme seriousness and vulnerability of patients with resistant anorexia the investigators want to assess the risk benefit ratio for the use of this technique in patients suffering from resistant anorexia nervosa The current data are too preliminary to consider a randomized controlled trial the investigators hope initially replicate the data from this pilot study in a second sample with a more rigorous and comprehensive assessment methodology
Detailed Description:
During stimulation the anode will be placed over the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex Stimulation of 2 milli-Ampere is applied for 25 minutes each session
20 sessions will be conducted twice a day respecting a period of four hours between sessions
The tDCS sessions will start maximum 15 days after the inclusion visit
Two intermediate control visits will be conducted One after the first week of tDCS the other immediately after the last session of tDCS
The main assessment visit will be carried out one month - 5 days after the last session of tDCS Finally a reminder visit will be performed 6 months - 3 weeks after the last session of tDCS to assess the stability over time of the potential effects observed
20 sessions will be conducted twice a day respecting a period of four hours between sessions
The tDCS sessions will start maximum 15 days after the inclusion visit
Two intermediate control visits will be conducted One after the first week of tDCS the other immediately after the last session of tDCS
The main assessment visit will be carried out one month - 5 days after the last session of tDCS Finally a reminder visit will be performed 6 months - 3 weeks after the last session of tDCS to assess the stability over time of the potential effects observed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-A00872-47 | OTHER | ANSM | None |