Clinical benefits of repeated cerebellar transcranial direct current stimulation sessions in Friedreich ataxia
| ISRCTN | ISRCTN10844276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10844276 |
| Secondary identifying numbers | B4062021000183 |
- Submission date
- 30/08/2023
- Registration date
- 07/09/2023
- Last edited
- 14/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Friedreich ataxia is a common type of ataxia (a neurological disorder affecting movement and coordination) that is passed down through genes. There's only one approved treatment for it in the United States. Scientists have discovered that using a type of brain stimulation called anodal cerebellar transcranial direct current stimulation (ctDCS) for one week can help reduce movement and thinking problems in people with Friedreich ataxia. In a study with a group of patients with cerebellar ataxia from mixed origin, doing this brain stimulation for more days (10 days instead of 5) in one go and then doing another round of it 12 weeks later can work even better for people with different kinds of ataxia. Now, researchers want to see if doing two rounds of 10 days of this brain stimulation, with a break of 12 weeks in between, is better than doing just one round of 10 days, followed by a fake stimulation session (sham) 12 weeks later. They want to figure out which approach improves movement and thinking problems in people with Friedreich ataxia more effectively.
Who can participate?
Patients with Friedreich ataxia who are aged over 14 to 100 years old
What does the study involve?
Patients will be randomly allocated to either two sessions of 10 days of anodal ctDCS (5 days/week for 2 weeks, 20 min/day, density current: 0.057 mA/cm2), separated by 12 weeks or one session of 10 days of anodal ctDCS followed by a sham ten days session 12 weeks later. Participants will be tested for improvement in their motor and cognitive symptoms in Friedreich Ataxia assessed by questionnaires.
What are the possible benefits and risks of participating?
A possible benefit is symptom improvement and risks are limited to local skin discomfort due to the ctDCS.
Where is the study run from?
HUB-Erasme Hospital (Belgium)
When is the study starting and how long is it expected to run for?
June 2021 to December 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof Gilles Naeije, gilles.naeije@hubruxelles.be (Belgium)
Contact information
Principal Investigator
Service de Neurologie
HUB-Hôpital Erasme
808, Route de Lennik
Brussels
1070
Belgium
 ORCID ID |
0000-0003-1580-1970 |
|---|---|
| Phone | +3225558196 |
| gilles.naeije@hubruxelles.be |
Scientific
Service de Neurologie
HUB-Hôpital Erasme
808, Route de Lennik
Brussels
1070
Belgium
| Phone | +3225558196 |
|---|---|
| gilles.naeije@hubruxelles.be |
Public
Service de Neurologie
HUB-Hôpital Erasme
808, Route de Lennik
Brussels
1070
Belgium
| Phone | +3225558196 |
|---|---|
| gilles.naeije@hubruxelles.be |
Study information
| Study design | Interventional randomized sham-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 44207_PIS_v2.0_17August2021.pdf |
| Scientific title | Clinical benefits assessment of two sessions of 10 days of cerebellar transcranial direct current stimulation (ctDCS) against one ten days session of ctDCS in mitigating Friedreich ataxia cognitive and motor symptoms, a randomised sham controlled study |
| Study objectives | There is a benefit of repeating 10 days session of ctDCS for mitigating Friedreich Ataxia cognitive and motor symptoms. |
| Ethics approval(s) |
Approved 23/08/2021, Erasmus ULB University Hospital, Ethics Committee (Comite d'éthique Hospitalo-facultaire, Erasme-ULB) (808, route de Lennik, Brussels, 1070, Belgium; +3225553707; comite.ethique@erasme.ulb.ac.be), ref: P2021/347 |
| Health condition(s) or problem(s) studied | Friedreich ataxia |
| Intervention | This study will test whether two sessions of 10 days of anodal cerebellar transcranial direct current stimulation (ctDCS) given using a brain stimulator, 5 days/week for 2 weeks, 20 min/day, density current: 0.057 mA/cm2, separated by 12 weeks are more effective than one session of 10 days of anodal ctDCS followed by a sham ten days session 12 weeks later in improving motor and cognitive symptoms in Friedreich Ataxia. Motor and cognitive performances will be assessed by a neurologist using the SARA score for ataxic motor symptoms and the CCAS-S scale for cognitive symptoms before and after each session of stimulation. Improvement will be evaluated by computing the difference in the two scores before and after each session of stimulation. To allocate subjects to either sham or anodal ctDCS as second session, the Randperm(2) function of MatLab will be used. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Anodal transcranial direct current stimulation using a stimulator |
| Primary outcome measure | 1. Motor symptoms measured using the Scale for the Assessment and Rating of Ataxia (SARA) before and after each stimulation session 2. Cognitive symptoms measured using the cerebellar cognitive affective syndrome scale (CCAS) before and after each stimulation session |
| Secondary outcome measures | Modification of resting state functional connectivity and brain fingerprints assessed by Magneto-encephalography recordings before and after ctDCS sessions |
| Overall study start date | 01/06/2021 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 14 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Patients with Friedreich ataxia 2. Aged > 14 to 100 years old |
| Key exclusion criteria | Intolerance to ctDCS |
| Date of first enrolment | 04/09/2023 |
| Date of final enrolment | 01/09/2024 |
Locations
Countries of recruitment
- Belgium
- Canada
Study participating centre
Bruxelles
1070
Belgium
Sponsor information
University/education
CAMPUS ERASME
808, route de Lennik
Brussels
1070
Belgium
| Phone | +3225556111 |
|---|---|
| contact@erasme.ulb.ac.be | |
| Website | https://www.ulb.be |
"ROR" |
https://ror.org/01r9htc13 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- F.R.S. - FNRS, Fund for Scientific Research - FNRS, Belgian National Fund for Scientific Research, FNRS
- Location
- Belgium
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- FA Research Alliance, FARA
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Gilles Naeije (gilles.naeije@hubruxelles.be). These data will be anonymized SARA and CCAS-S results and will be available after completion of the study. Consent from participants was required and obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 17/08/2021 | 07/09/2023 | No | Yes |
Additional files
Editorial Notes
14/09/2023: The overall study start date has been changed from 31/12/2022 to 01/06/2021 and the plain English summary updated accordingly.
08/09/2023: Internal review.
07/09/2023: Study's existence confirmed by the Erasmus-ULB Ethics Committee (Brussels).
